PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

AT THE TIME OF THE INITIAL MDR SUBMISSION FOR THIS EVENT, THE INVESTIGATION INTO THE CAUSE OF THIS EVENT WAS STILL UNDERWAY. THIS FOLLOWUP MDR IS SUBMITTED TO SUBMIT NEW INFORMATION, INCLUDING INVESTIGATION FINDINGS CODES. INVESTIGATION CONCLUSION CODES. MANUFACTURER'S NARRATIVE WITH THE FIRM'S ROOT CAUSE CONCLUSIONS. ADDITIONAL FOLLOWUP FROM THE USER: THE USER AND TREATING INSTITUTION WERE UNABLE TO DETERMINE THE CAUSE OF DEATH. BASED ON TESTING PERFORMED IN THE ICU, THE USER NOTES A POSSIBLE CAUSE WAS A CLINICALLY RELEVANT EMBOLIC PHENOMENON (EITHER PULMONARY EMBOLISM OR FAT EMBOLI), OR MYOCARDIAL INFARCTION. MEDICAL OVERSIGHT REVIEW: THE FIRM HOSTED AN INTERNAL MEDICAL OVERSIGHT REVIEW OF THE CASE INFORMATION KNOWN. · INTERNAL MEDICAL OVERSIGHT OBSERVED THAT THE PATIENT WAS IN THE PRONE POSITION, AND THE PRONE POSITION CAN MAKE OXYGENATION MORE DIFFICULT DUE TO THE PRESSURE ON THE LUNGS. IT WAS ALSO NOTED THAT THIS PATIENT HAD MULTIPLE COMORBIDITIES (LUNG CANCER, COPD, HISTORY OF SMOKING). ·THE FIRM REQUESTED ANESTHESIA PRE-OP ASSESSMENT AND OPERATIVE ANESTHESIA RECORDS FOR THIS CASE, HOWEVER THEY WERE NOT AVAILABLE TO THE FIRM. IN THE ABSENCE OF AN AUTOPSY, FURTHER MEDICAL RECORDS, OR A STATED CAUSE OF DEATH FROM THE USER OR TREATING INSTITUTION, MEDICAL OVERSIGHT CONCLUDED THAT THERE ARE MULTIPLE POSSIBLE CAUSES BASED ON THE INFORMATION KNOWN. OF THESE, THE MOST LIKELY CAUSE OF THE PATIENT DECLINE WAS DUE TO A PULMONARY EMBOLISM (PE), AS THE PATIENT EXPERIENCED RIGHT SIDE HEART FAILURE IN THE ICU, WHICH CAN OCCUR AFTER A PE WHEN A BLOOD CLOT TRAVELS TO THE LUNGS. IT WAS OBSERVED THAT FAT EMBOLISM IS LESS LIKELY THAN A PE GIVEN WHAT IS KNOWN ABOUT THIS CASE, ALTHOUGH THIS CANNOT BE RULED OUT, NOR CAN OTHER POTENTIAL CAUSES. A LITERATURE SEARCH WAS CONDUCTED TO SUPPLEMENT THIS INVESTIGATION INTO THE POTENTIAL CAUSES OF THE PATIENT DEATH. THIS LITERATURE REVIEW CONFIRMED THAT THE RISK OF MORTALITY FOR FRACTURE PATIENTS IS MOST SIGNIFICANTLY CONTRIBUTED TO BY PATIENT AGE (<65), PATIENT COMORBIDITIES, AND ALSO THE BONE IN WHICH THE FRACTURE IS EXPERIENCED, AND THE TRAUMATIC NATURE OF THE FRACTURE. SPECIFICALLY, PATIENTS EXPERIENCING FRACTURE OF THE LONG BONES AND PELVIS (FEMUR, HUMERUS, TIBIA, PELVIS) ARE MORE AT RISK THAN SIMILAR PATIENTS WITH FRACTURES IN OTHER BONES. IN THIS CASE THE BONE BEING TREATED WAS THE PELVIS FOR A METASTATIC LESION, AND THE PATIENT WAS ELDERLY (79), HAD BEEN TREATED WITH RADIATION, AND HAD MULTIPLE COMORBIDITIES INCLUDING LUNG CANCER AND COPD. A SURGICAL PROCEDURE OF ANY KIND - INCLUDING ONE TO FIXATE THE FRACTURE - INCREASES THE RISK FOR MORBIDITY AND MORTALITY. THIS LITERATURE REVIEW CONFIRMED THAT THE RISK OF THROMBOEMBOLIC EVENT DUE TO PATIENT CO-MORBIDITIES, AND PULMONARY EMBOLISM FROM A CLOT IS A RISK FOR THIS PATIENT POPULATION. THIS LITERATURE REVIEW CONFIRMED THAT THERE IS A RISK OF FAT EMBOLISM FOR THIS PATIENT POPULATION FROM AN IM FIXATION PROCEDURE. THIS LITERATURE REVIEW ALSO CONFIRMED THAT MYOCARDIAL INFARCTION DUE TO PATIENT CO-MORBIDITIES IS ALSO A RISK FOR THIS PATIENT POPULATION. THIS LITERATURE SEARCH ALSO CONFIRMED THAT THERE IS A SIGNIFICANT POSITIVE CORRELATION FOUND BETWEEN LUNG-CANCER HISTOLOGY AND THE DEVELOPMENT OF VTE OR PE. THE ABSENCE OF RADIATION THERAPY APPROACHED SIGNIFICANCE WITH RESPECT TO DECREASED OVERALL VTE RISK, THEREFORE HAVING BOTH RADIATION AND LUNG CANCER PUT THIS PATIENT AS A SIGNIFICANTLY HIGHER RISK FOR VTE. MEDICAL OVERSIGHT CONFIRMED THAT THIS PATIENT'S LUNG CANCER, COPD AND HISTORY OF RADIATION TREATMENTS MAY HAVE BEEN CLINICALLY SIGNIFICANT RISK FACTORS CONTRIBUTING TO THIS ADVERSE EVENT. REVIEW OF IFU A REVIEW OF US IMPLANT IFU 900356 REV. W WAS PERFORMED. THERE IS NO INDICATION THAT THE USER DEVIATED FROM THE MANUFACTURER'S INSTRUCTIONS FOR INTENDED USE OF THE PRODUCT. THE IFU CONTAINS THE RISK THAT "AS WITH ANY IM FIXATION SYSTEM, THE FOLLOWING CAN OCCUR: THROMBOEMBOLIC EVENT OR FAT EMBOLISM (BLOOD CLOT, FAT, OR OTHER MATERIAL THAT COULD RESULT IN ORGAN DAMAGE OR FAILURE)". CONCLUSION: THE CAUSE OF THE PATIENT'S DEATH IN THIS CASE REMAINS UNKNOWN. BASED ON THE AVAILABLE INFORMATION, MEDICAL OVERSIGHT REVIEW, AND THE LITERATURE REVIEW PERFORMED, A PROBABLE CAUSE OF THIS PATIENT'S DEATH WAS IDENTIFIED AS AN EMBOLIC EVENT (MOST LIKELY PULMONARY EMBOLISM BASED OFF OF THE CLINICAL EVENTS THE PATIENT EXPERIENCED, BUT MAY ALSO HAVE BEEN FAT EMBOLISM) RELATED TO THE SURGICAL PROCEDURE, THE PATIENT'S MEDICAL HISTORY OF LUNG CANCER, COPD, RADIATION TREATMENT AND PATIENT AGE. THE HOSPITAL AND USER WERE UNABLE TO DETERMINE THE CAUSE OF DEATH, AND NO AUTOPSY WAS PERFORMED. WITHOUT AN AUTOPSY, FURTHER MEDICAL RECORDS, OR A CONCLUSION FROM THE TREATING PHYSICIAN ABOUT A KNOWN CAUSE OF DEATH, THE FOLLOWING POSSIBLE CAUSES COULD NOT BE RULED OUT: A FAT EMBOLISM RELEASED BY THE FRACTURE OR THE DEVICE IMPLANTATION INTO THE INTRAMEDULLARY CANAL; THE PATIENT'S PRE-EXISTING CO-MORBIDITIES; OR A PRIMARY CARDIAC EVENT RELATED TO THE STRESS OF THE ANESTHESIA. OF THESE POSSIBLE CAUSES, THE RISKS THAT MAY BE DEVICE-USE RELATED ARE EXPLAINED IN THE DEVICE LABELING AND RISK DOCUMENTATION. SPECIFICALLY, "THROMBOEMBOLIC EVENT OR FAT EMBOLISM (BLOOD CLOT, FAT, OR OTHER MATERIAL THAT COULD RESULT IN ORGAN DAMAGE OR FAILURE)." THERE IS NO INDICATION THAT THIS EVENT WAS THE RESULT OF A MALFUNCTION, FAILURE OR CHANGE IN THE CHARACTERISTICS OR PERFORMANCE OF THE DEVICE, OR DEVICE MISUSE.

Description of Event or Problem

DURING A PROCEDURE TO TREAT A 79 YEAR OLD MALE FOR A PELVIC DEFECT WITH ONE ILLUMINOSS IMPLANT, THE PATIENT DECLINED WHILE CURING OF THE BALLOON IN SURGERY. THE PATIENT PASSED WITHIN TWO HOURS LATER IN THE ICU.

Additional Manufacturer Narrative

AT THE TIME OF THIS INITIAL MDR REPORT, THE INVESTIGATION INTO THE CAUSE OF THE EVENT IS STILL ONGOING. RETURNED PRODUCT EVALUATION: DEVICE EVALUATION IN THIS CASE IS NOT POSSIBLE AS THE DEVICE REMAINED IMPLANTED. DHR REVIEW: A REVIEW OF MANUFACTURING RECORDS FOR THE PRODUCT INVOLVED IN THIS COMPLAINT WAS PERFORMED, AND FOUND THAT THE PRODUCT MET SPECIFICATIONS AT THE TIME OF MANUFACTURE AND RELEASE. FOLLOW UP WITH USER: THE TREATING PHYSICIAN MET WITH THE FIRM'S REPRESENTATIVES TO PROVIDE ADDITIONAL FOLLOW-UP INFORMATION: ·THE PATIENT WAS 79 YEARS OLD WITH METASTATIC LUNG CANCER UNDER REASONABLE CONTROL. HE HAD A LARGE LESION IN THE ACETABULUM WHICH HAD BEEN TREATED WITH RADIATION, WHICH HAD GOOD CANCER EFFECT BUT LEFT A LARGE DEFECT IN THE ACETABULUM AND HIS BONE QUALITY WAS POOR. ·DURING THE IMPLANTATION PROCEDURE, THE SURGEON REAMED UP TO 8MM IN THE PELVIS AND THE CASE WAS PROGRESSING SMOOTHLY. ·THE ILLUMINOSS IMPLANT WAS PLACED, INFUSED WITH MONOMER, AND CURING HAD BEGUN. ·2.5 MINUTES INTO CURING PROCESS THE PATIENT HAD A CARDIO PULMONARY ISSUE AND WAS HYPOTENSIVE. THE PATIENT RECEIVED MEDICATION AND WAS STABILIZING, SO THE REMAINING 14 MINUTES OF IMPLANT CURING WAS COMPLETED, THEN THE PATIENT WAS TRANSFERRED TO THE ICU. ·WITHIN 2 HOURS THE PATIENT WORSENED, AND PASSED. ·THE HOSPITAL AND USER WERE UNABLE TO DETERMINE THE CAUSE OF DEATH, AND NO AUTOPSY WAS PERFORMED. X-RAYS: RADIOGRAPHS OF THE TREATED ANATOMY WERE RECEIVED FROM THE USER. MEDICAL OVERSIGHT REVIEW: THE FIRM IS IN THE PROCESS OF PERFORMING AN INTERNAL MEDICAL OVERSIGHT REVIEW OF THE CASE, IN WHICH THE RECORDS AND INFORMATION KNOWN ABOUT THE CASE ARE BEING REVIEWED. THE INTERNAL MEDICAL OVERSIGHT REVIEW OF THIS CASE IN ON-GOING AT THE TIME OF THIS REPORT. A FOLLOW UP MDR WILL BE SUBMITTED WHEN THESE ONGOING ACTIVITIES ARE COMPLETE.