PHOTODYNAMIC BONE STABILIZATION SYSTEM

Description of Event or Problem

ON (B)(6) 2024 A 77 YEAR OLD FEMALE WAS TREATED FOR A DISTAL FEMUR FRACTURE. THIS PATIENT WAS OBESE, HIGH RISK, AND HAD A TOTAL KNEE IMPLANT A FEW WEEKS PRIOR ON MAY 6TH. THE DOCTOR WAS DOING A RETROGRADE FEMORAL NAIL APPROACH AND DID NOT REAM THE CANAL. A 22/13X220MM IMPLANT WAS INSERTED AND THE PLAN WAS TO PLATE IT. ABOUT HALFWAY THROUGH THE CURING PROCESS THE PATIENT'S HEART RATE DROPPED. THEY TRIED TO GET THE PATIENT'S HEART RATE BACK UP. THE DOCTOR DETACHED THE LIGHT FIBER FROM THE LIGHT BOX AND STOPPED THE CURING. THEY CLOSED THE PATIENT UP AND CONTINUED TO WORK ON THE PATIENT, PERFORMING CPR. THEY WERE UNABLE TO GET THE PATIENT BACK AND THEY PASSED.

Additional Manufacturer Narrative

A MEDICAL OVERSIGHT REVIEW MEETING WAS HELD ON (B)(6) 2024. THE TEAM DISCUSSED IF THERE WAS ANY EVIDENCE OF MONOMER LEAKAGE DURING THE PROCEDURE, AND THERE WAS NO EVIDENCE OR REASON TO BELIEVE THERE WAS MONOMER LEAKAGE DURING THE PROCEDURE. THE REP PRESENT DURING THE IMPLANTATION PORTION OF THE PROCEDURE CONFIRMED THERE WAS NO EVIDENCE OF BALLOON LEAKAGE. THE MEDICAL REVIEWER OBSERVED THAT THE PATIENT WAS ONLY 3 WEEKS OUT FROM A TOTAL KNEE IMPLANTATION PROCEDURE, AND WONDERED IF SHE WAS ON ANTICOAGULANTS. THE MEDICAL REVIEWER STATED THAT 3 WEEKS IS NOT A LONG TIME AFTER A KNEE REPLACEMENT PROCEDURE AND THE PATIENT COULD HAVE EXPERIENCED A THROMBOEMBOLIC PHENOMENON FROM THIS PRIOR PROCEDURE. THE TOTAL KNEE REPLACEMENT PROCEDURE COULD HAVE CAUSED A BLOOD CLOT TO EMBOLIZE, WHICH IS WHY IT WOULD BE USEFUL TO KNOW IF THE PATIENT WAS ON ANTICOAGULANTS, WHICH IS STANDARD AFTER A KNEE REPLACEMENT. THE MEDICAL REVIEWER N STATED THAT IT WOULD BE USEFUL TO HAVE ADDITIONAL INFORMATION FROM THE USER ABOUT THE PATIENT'S BLOOD PRESSURE AND HEART RATE DURING THE EVENT, OTHER THAN THAT THE HEART RATE DROPPED. THE MEDICAL REVIEWER ALSO STATED IT WOULD ALSO BE USEFUL TO THE INVESTIGATION TO HAVE MORE INFORMATION ABOUT THE PATIENT COMORBIDITIES, PRIOR MEDICAL HISTORY, AND ANY INFORMATION IF AN AUTOPSY WAS PERFORMED. THE MEDICAL REVIEWER WAS UNABLE TO DRAW A CONCLUSION ABOUT THE CAUSE OF THE PATIENT DECLINE AND DEATH WITH THE AVAILABLE INFORMATION. MORE THAN 3 REQUESTS FOR FOLLOW-UP INFORMATION WERE MADE TO THE USER AND NO ADDITIONAL INFORMATION OR ANSWERS TO THE FOLLOW UP QUESTIONS WERE PROVIDED BY THE USER. THE USER WAS NOT CERTAIN WHAT INFORMATION HE WAS ALLOWED TO DISCUSS WITH ILLUMINOSS AT THIS TIME. FOLLOW UP INFORMATION THE USER DID NOT PROVIDE ANY FOLLOW UP INFORMATION TO THE REQUESTS. THE REPS PRESENT DURING THE CASE WERE CONTACTED AND THE FOLLOWING INFORMATION WAS PROVIDED: THE MEDULLARY CANAL WAS NOT REAMED, AS THE USER DOES NOT TYPICALLY REAM WHEN PERFORMING CASES LIKE THIS WHERE A PLATE WAS PLANNED TO BE USED. THE REP STATED THIS WAS A RETROGRADE FEMORAL NAIL APPROACH, THEY CREATED A SMALL INCISION, USED AN ENTRY REAMER AND THEN PUT THE BALLOON IN THE IMPLANT. THE BALLOON WAS INSERTED, FULLY INFLATED AND THE LIGHT BOX ACTIVATED, ABOUT 15 MINUTES INTO CURING THE PATIENT'S HEAR RATE DROPPED AND THE REST OF THE SURGERY CAME TO A PAUSE SO THE ANESTHESIOLOGIST COULD TREAT THE PATIENT. THEY COULD NOT GET THE PATIENT'S HEART RATE UP, SO THEY CALLED MORE MEDICAL STAFF INTO THE ROOM AND ASKED THE REP TO LEAVE. AFTER THE REP LEFT THE ROOM, THE USER DETACHED THE LIGHT FIBER FROM THE LIGHT BOX AND STOPPED THE CURING. THEY CLOSED THE PATIENT UP AND CONTINUED TO WORK ON THE PATIENT FOR 30 MINUTES DOING CPR. THE REP STATED THERE WAS NO EVIDENCE OF BALLOON MONOMER LEAK. THE REP STATED THAT THE PATIENT IS VERY OBESE, SHORT IN STATURE, AND MEDICALLY HIGH RISK, BUT DOES NOT KNOW ANY MORE DETAILS ABOUT THE PATIENT'S MEDICAL HISTORY OR CONDITION. DHR REVIEW: THE DHR OF THE DEVICE USED WAS REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. RETURNED PRODUCT EVALUATION: NO RETURNED PRODUCT WAS AVAILABLE AS THE DEVICE WAS IMPLANTED IN THE PATIENT WHEN THEY PASSED AND WAS NOT ABLE TO BE RETURNED. IFU REVIEW: INSTRUCTIONS FOR USE 900356_X STATES THAT RISKS INCLUDE THROMBOEMBOLIC EVENT OR FAT EMBOLISM (BLOOD CLOT, FAT, OR OTHER MATERIAL THAT COULD RESULT IN ORGAN DAMAGE OR FAILURE). THE FEMUR AND TIBIA SURGICAL TECHNIQUE GUIDE 900611_C INCLUDES INSTRUCTIONS FOR BOTH VENTING AND PREPARATION OF THE CANAL WITH REAMERS. THE STG STATES THAT VENTING MAY REDUCE INTRAMEDULLARY PRESSURE ON THE BONE MARROW DURING REAMING AND IMPLANT INSERTION, AND REAMING WILL FACILITATE SAFER PASSAGE OF THE BALLOON IMPLANT AND MAY HELP TO REDUCE INTRAMEDULLARY PRESSURE WHEN THE MONOMER IS DEPLOYED. POTENTIAL FOR USER ERROR: IN THIS CASE THE USER DID NOT REAM THE CANAL PRIOR TO IMPLANT INSERTION. PER THE STG 900611_C PREPARATION OF THE CANAL WITH REAMERS IS A STEP IN THE PROCEDURE AND REAMING WILL FACILITATE SAFER PASSAGE OF THE BALLOON IMPLANT AND MAY HELP TO REDUCE INTRAMEDULLARY PRESSURE WHEN THE MONOMER IS DEPLOYED. BASED ON THE INFORMATION PROVIDED IT IS UNKNOWN WHAT THE CAUSE OF THE PATIENT DECLINE AND DEATH IS, SO IT IS UNKNOWN IF A LACK OF REAMING PRIOR TO PLACING THE IMPLANT CONTRIBUTED TO THE COMPLAINT. CONCLUSION: THE ROOT CAUSE OF THIS COMPLAINT IS UNKNOWN WITH THE INFORMATION AVAILABLE. THERE IS NO INDICATION THAT THE ILLUMINOSS DEVICE MALFUNCTIONED OR CONTRIBUTED TO THIS COMPLAINT. THIS PATIENT HAD A TOTAL KNEE REPLACEMENT PROCEDURE 3 WEEKS PRIOR TO THE ILLUMINOSS PROCEDURE, SO IT IS POSSIBLE THAT THE KNEE REPLACEMENT CAUSED A BLOOD CLOT TO EMBOLIZE. AS NO FOLLOW UP INFORMATION OR AUTOPSY INFORMATION WAS RECEIVED, THE ROOT CAUSE OF THE PATIENT DEATH IS UNKNOWN.

Description of Event or Problem

ON (B)(6) 2024 A 77 YEAR OLD FEMALE WAS TREATED FOR A DISTAL FEMUR FRACTURE. THIS PATIENT WAS OBESE, HIGH RISK, AND HAD A TOTAL KNEE IMPLANT A FEW WEEKS PRIOR ON (B)(6). THE DOCTOR WAS DOING A RETROGRADE FEMORAL NAIL APPROACH AND DID NOT REAM THE CANAL. A 22/13X220MM IMPLANT WAS INSERTED AND THE PLAN WAS TO PLATE IT. ABOUT HALFWAY THROUGH THE CURING PROCESS THE PATIENT'S HEART RATE DROPPED. THEY TRIED TO GET THE PATIENT'S HEART RATE BACK UP. THE DOCTOR DETACHED THE LIGHT FIBER FROM THE LIGHT BOX AND STOPPED THE CURING. THEY CLOSED THE PATIENT UP AND CONTINUED TO WORK ON THE PATIENT, PERFORMING CPR. THEY WERE UNABLE TO GET THE PATIENT BACK AND THEY PASSED.

Additional Manufacturer Narrative

THE DHR OF THE DEVICE USED WAS REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. NO RETURNED PRODUCT WAS AVAILABLE AS THE DEVICE WAS IMPLANTED IN THE PATIENT WHEN THEY PASSED AND WAS NOT ABLE TO BE RETURNED. THE COMPANY HAS REACHED OUT TO THE SURGEON FOR ADDITONAL INFORMATION.