VASERLIPO SYSTEM AND ACCESSORIES

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING.

Description of Event or Problem

A USER FACILITY REPORTED A BURN TO THE LEFT FLANKS 3 DAYS POST VASER SURGERY. THE USER FACILITY REPORTED THAT THE AREAS OF THE BODY TREATED BY THE VASER INCLUDE THE BACK, ABDOMEN, FLANKS, INNER THIGHS, AND ARMS. THE PATIENT WAS PRESCRIBED SILVADENE AS WELL AND HYPERBARIC OXYGEN TREATMENTS. THE CURRENT STATUS IS UNKNOWN WITH A PERMANENT SCAR. AVAILABLE PICTURES WERE REVIEWED. THE IMAGES DEPICT A LARGE, BURNED AREA WITH VISIBLE CRUSTS. THE CRUSTS HAVE SINCE RESOLVED, LEAVING RESIDUAL POST-INFLAMMATORY HYPERPIGMENTATION ON THE FLANK AREA. IT IS REPORTED THAT THE VASER AMPLIFIER AND HAND PIECE WERE MALFUNCTIONING. RENUVION WAS ALSO USED TO THE BACK, ABDOMEN, FLANKS, AND INNER THIGHS. THE PATIENT HAD NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS, NOR HAS THE PATIENT EVER HAD PRIOR AESTHETIC TREATMENTS ON THIS AREA. NO TESTING OF THE SYSTEM WAS PERFORMED PRIOR TO TREATMENT. IN THAT AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER MODE. IN THE AREA WHERE THE INJURY OCCURRED, THE HIGHEST AMPLITUDE LEVEL USED WAS 50%. NO SYSTEM ERRORS OCCURRED, NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF VASER DELIVERY WAS 39 MINS AND 58S - 20 MINS 37S FOR THE BACK, FLANKS, ARMS, AND POSTERIOR INNER THIGHS, 19 MINS 19S FOR THE ABDOMEN AND ANTERIOR INNER THIGHS. 4.6L OF TUMESCENT FLUID WAS USED - 1.4L IN THE BACK, FLANKS, ARMS, AND POSTERIOR INNER THIGHS, 3.2L FOR THE ABDOMEN AND ANTERIOR INNER THIGHS. 2.5L LIPO ASPIRATE WAS REMOVED AFTER FRAGMENTATION FROM THE BACK, FLANKS, ARMS, POSTERIOR INNER THIGHS WITH 2.5L REMOVED FROM THE ABDOMEN AND ANTERIOR INNER THIGHS. TREATMENT USING THE VASER WAS COMPLETED. A VENTX WAS NOT USED AND THE MICROAIRE PAL WAS. A SKIN PORT WAS USED AND WAS NOT DAMAGED OR MISALIGNED. A WET TOWEL BARRIER WAS UTILIZED TO PROTECT SKIN FROM PROBE CONTACT. A 2-RING PROBE WAS USED FOR THE BACK, FLANKS, ARMS AND POSTERIOR INNER THIGHS, AND 3 RING FOR THE ABDOMEN AND ANTERIOR INNER THIGHS. THE PROBE/CANNULA USED IN THIS TREATMENT, HAS BEEN USED TO TREAT OTHER PATIENTS.

Description of Event or Problem

THE DOCTOR NOTED THAT HE DID USE THE VENTX DURING THE AE. UPDATED INFORMATION WAS ALSO RECEIVED THAT INCLUDED TEXT MESSAGES AND MEDICAL RECORDS. AFTER A COMPREHENSIVE EVALUATION, THE PATIENT WAS DEEMED AN APPROPRIATE CANDIDATE FOR LIPOSUCTION TARGETING ALL OF AREAS MENTIONED IN THE PREVIOUS REPORT. THE PATIENT UNDERWENT LIPOSUCTION OF THE BACK, ABDOMEN, FLANKS, ARMS, AND INNER THIGHS AND TOLERATED THE PROCEDURE WELL. THERE WERE NO IMMEDIATE INTRAOPERATIVE OR POSTOPERATIVE COMPLICATIONS NOTED IN THE RECOVERY ROOM. THE PATIENT WAS SEEN FOR THE FIRST POSTOPERATIVE FOLLOW-UP VISIT 10 DAYS AFTER SURGERY. THE PATIENT HAD CONTACTED THE OFFICE VIA TEXT MESSAGE ON POSTOPERATIVE DAY 3¿4, REPORTING THAT THE SKIN ON THE FLANK HAD INADVERTENTLY BEEN ZIPPED INTO THE COMPRESSION GARMENT BY A RECOVERY ROOM NURSE. DURING THE IN-PERSON VISIT, THE PATIENT'S PARTNER CORROBORATED THIS ACCOUNT, NOTING THAT UPON REMOVAL OF THE GARMENT, THE AFFECTED AREA APPEARED SWOLLEN, WITH SKIN BILLOWING OUTWARD AND A LARGE BLOOD BLISTER PRESENT. UPON EXAMINATION, THE PATIENT HAD A DEEP PARTIAL-THICKNESS SKIN LOSS ON THE RIGHT FLANK. THERE WAS EVIDENCE OF SUPERFICIAL EPIDERMOLYSIS; HOWEVER, THE FULL DEPTH OF THE TISSUE INJURY COULD NOT BE DEFINITIVELY ASSESSED AT THAT TIME. THE PATIENT REPORTED USING DMSO (DIMETHYL SULFOXIDE), WHICH HAD BEEN PROVIDED ON POSTOPERATIVE DAY 3 FOR TOPICAL APPLICATION TO THE AFFECTED AREA. DUE TO THE EXTENT OF THE SKIN INJURY AND TO SUPPORT OPTIMAL WOUND HEALING, THE PATIENT WAS REFERRED FOR HYPERBARIC OXYGEN (HBO) THERAPY. INSTRUCTIONS WERE GIVEN REGARDING CONTINUED WOUND CARE AND WAS ADVISED TO MONITOR FOR SIGNS OF INFECTION OR DELAYED HEALING. AT THE ONE-MONTH POSTOPERATIVE APPOINTMENT, THE PATIENT WAS REPORTED TO BE IN GOOD OVERALL CONDITION. THE PATIENT'S CONTOUR AND SHAPE WERE DESCRIBED AS EXCELLENT, AND THE WOUND ON THE RIGHT FLANK SHOWED SIGNIFICANT IMPROVEMENT WITH EVIDENCE OF ONGOING HEALING. THE PATIENT WAS ADVISED TO CONTINUE THE WOUND CARE REGIMEN UNTIL THE ESCHAR (DEAD TISSUE) FULLY DETACHED. ADDITIONAL SUPPORTIVE TREATMENTS WERE DISCUSSED, AND A PLAN WAS MADE FOR TO RETURN FOR A THREE-MONTH FOLLOW-UP TO ASSESS LONG-TERM HEALING, AESTHETIC OUTCOME, AND ANY FURTHER TREATMENT NEEDS. PATIENT TEXT MESSAGES WERE REVIEWED. SHORTLY AFTER SURGERY, THE PATIENT REPORTED EXPERIENCING PAIN, WHICH WAS DISCUSSED WITH THE PHYSICIAN. THE PHYSICIAN REASSURED THE PATIENT THAT POSTOPERATIVE PAIN WAS EXPECTED AND PRESCRIBED APPROPRIATE PAIN MEDICATION. AT THAT TIME, THE PATIENT HAD NO ADDITIONAL CONCERNS. SUBSEQUENTLY, THE PATIENT SHARED A PHOTOGRAPH OF THE RIGHT FLANK, EXPRESSING CONCERN THAT THE AREA OF INJURY WAS RELATED TO THE COMPRESSION GARMENT. ALTHOUGH THE IMAGE QUALITY WAS SUBOPTIMAL, A HYPERPIGMENTED AREA WAS VISIBLE. THE PHYSICIAN ADVISED THE PATIENT TO OBTAIN AND APPLY A TOPICAL CREAM TO THE AFFECTED AREA AND INQUIRED WHETHER THE GARMENT HAD FELT TIGHT IN THAT REGION. THE PATIENT CONFIRMED THAT THE AREA HAD FELT PINCHED. THE PATIENT SHARED A SERIES OF PHOTOGRAPHS OVER TIME TO DOCUMENT THE PROGRESSION OF THE WOUND. OVER THE FOLLOWING DAYS, ADDITIONAL IMAGES SUBMITTED BY THE PATIENT DEMONSTRATED THE EVOLUTION OF THE WOUND. THE AFFECTED AREA BEGAN TO DEVELOP VISIBLE CRUSTING, INDICATING THE NATURAL FORMATION OF A PROTECTIVE SCAB OVER THE INJURED SKIN. AS TIME PROGRESSED, THE PHOTOS SHOWED A GRADUAL REDUCTION IN ERYTHEMA AND INFLAMMATION, ALONG WITH A CLEAR DEMARCATION OF HEALING TISSUE. THE WOUND APPEARED TO BE CONTRACTING AND RE-EPITHELIALIZING FROM THE EDGES INWARD, WHICH IS CONSISTENT WITH NORMAL WOUND HEALING. THE LATER IMAGES SHOWED A DRIER SURFACE, DECREASED CRUSTING, AND EARLY SIGNS OF PIGMENT NORMALIZATION IN SOME AREAS, ALTHOUGH PATCHES OF HYPERPIGMENTATION REMAINED. THE PHYSICIAN REASSURED THE PATIENT THAT THE AREA APPEARED TO BE HEALING AND NOTED THAT WHILE SOME HYPERPIGMENTATION MAY PERSIST, IT IS EXPECTED TO IMPROVE OVER TIME. DISCUSSION WITH THE PHYSICIAN ALSO INCLUDED RECOMMENDATIONS FOR CONTINUED WOUND CARE AND THE POTENTIAL NEED FOR EVALUATION BY A WOUND CARE SPECIALIST. INSURANCE COVERAGE FOR SPECIALIST EVALUATION AND TREATMENT OPTIONS WAS ALSO ADDRESSED.

Additional Manufacturer Narrative

THE DEVICE IS BEING RETURNED AND IS EXPECTED TO BE EVALUATED. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NONCONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. THE INVESTIGATION IS UNDERWAY.

Description of Event or Problem

ADDITIONAL MEDICAL RECORDS WERE RECEIVED AND REVIEWED BY THE SOLTA MEDICAL REVIEWER. THE FILES INCLUDE SUPPORTING INFORMATION THAT RENUVION WAS PERFORMED TO THE BACK, ABDOMEN, FLANKS, AND INNER THIGHS; AND ULTRASOUND-GUIDED RECTUS ABDOMINIS FAT TRANSFER (UGRAFT). DURING THE PROCEDURE, SOLTA VASER LIPO PRODUCTS WERE USED. POST-PROCEDURE, THE PATIENT DEVELOPED A MAJOR BURN INJURY TO THE RIGHT FLANK WITH NECROSIS AND SUBSEQUENT PERMANENT SCARRING. CLINICAL COURSE AND REPORTED INJURIES. INITIAL FINDINGS (10 DAYS POST-OP): DEEP PARTIAL SKIN LOSS AT RIGHT FLANK, SUPERFICIAL EPIDERMOLYSIS. 1-MONTH POST-OP: WOUND PRESENT BUT REPORTED TO BE HEALING; PATIENT INSTRUCTED TO USE SANTYL OINTMENT AND COMPRESSION GARMENT. SUBSEQUENT CLINICAL COURSE: DEVELOPMENT OF EXTENSIVE CUTANEOUS NECROSIS, OPEN WOUND OF LOWER BACK AND PELVIS, ISCHEMIC ULCERATION WITH FAT LAYER EXPOSED, AND INFECTION. TREATMENTS INCLUDED SELECTIVE EXCISIONAL DEBRIDEMENT, HYPERBARIC OXYGEN THERAPY, TOPICAL THERAPIES (SILVADENE, SANTYL, COLLAGENASE, DAKIN¿S SOLUTION), AND SYSTEMIC MEDICATIONS (GABAPENTIN, CEPHALEXIN, OXYCODONE-ACETAMINOPHEN). HYPOBARIC THERAPY WAS INITIATED BUT COMPLICATED BY INTOLERANCE (ANXIETY, SHIVERING, NAUSEA, AND PAIN). THERAPY WAS ABORTED DURING AT LEAST ONE SESSION. IN ADDITION, CULTURES CONFIRMED WOUND INFECTION WITH MSSA, E. COLI, AND PEPTOSTREPTOCOCCUS MAGNUS. WOUND CARE CONTINUED UNDER A SPECIALIST WITH SERIAL DEBRIDEMENT, ANTIMICROBIAL DRESSINGS, AND WOUND MANAGEMENT PROTOCOLS. OUTCOME: THE PATIENT EXPERIENCED PERMANENT DISFIGURING SCARRING OF THE RIGHT FLANK. DESPITE WOUND CLOSURE, THE PATIENT CONTINUES TO SUFFER FROM COSMETIC AND PSYCHOSOCIAL IMPACT, INCLUDING SELF-CONSCIOUSNESS AND RESTRICTION OF CLOTHING CHOICE. NO EFFECTIVE SCAR REVISION OPTIONS ARE CURRENTLY AVAILABLE. THE MEDICAL REVIEWER OBSERVED PHOTOGRAPHIC DOCUMENTATION OF WOUND PROGRESSION AND SCAR FORMATION AT DIFFERENT ANGLES IN MULTIPLE PICTURES. A SERIES OF PHOTOGRAPHS TAKEN OVER AN APPROXIMATE TWO-YEAR PERIOD INCLUDED IMAGES OF THE PATIENT¿S FLANK. THE PHOTOGRAPHS DOCUMENT THE INITIAL PRESENTATION OF A LARGE BURN INJURY, THE SUBSEQUENT HEALING PROCESS, AND THE PROGRESSION TO SCAR FORMATION. THE FINAL IMAGES DEMONSTRATE THAT THE BURN RESULTED IN A PERMANENT SCAR.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING.

Description of Event or Problem

SOLTA LEGAL WAS NOTIFIED A VASER LIPOSUCTION PRODUCT AND A RENUVION PRODUCT WERE DEFECTIVE. THE COURT FILING REPORTS THAT THE USER FACILITY NEGLIGENTLY PERFORMED MEDICAL PROCEDURES ON THE PLAINTIFF INCLUDING, BUT NOT RELATED TO, LIPOSUCTION, RENUVION, AND LGRAFT, AND SUBSEQUENT FOLLOW-UP MEDICAL SERVICES, RESULTING IN SIGNIFICANT PERSONAL INJURIES, AND NECESSITATING MULTIPLE SUBSEQUENT MEDICAL PROCEDURES. NO OTHER INFORMATION IS AVAILABLE. ATTEMPTS ARE BEING MADE TO GATHER DETAILS.

Additional Manufacturer Narrative

THE INVESTIGATION IS UNDERWAY.