PENDITURE LAA EXCLUSION SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT AFTER SURGERY THE PENDITURE CLIP, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED SEVERAL DAYS LATER AND IT WAS OBSERVED THAT THE CLIP HAD SLIPPED OFF, RESULTING IN A 2CM RESIDUAL STUMP. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CONCOMITANT PROCEDURE WAS AN AORTIC VALVE REPLACEMENT (AVR), IN COMBINATION WITH CORONARY ARTERY BYPASS GRAFT (CABG) X3. THE CLIP WAS NOT DEPLOYED ON A BEATING HEART. A SIZER WAS USED TO DETERMINE THE CLIP SIZE. THE IMPLANT TECHNIQUE WAS FULL STERNOTOMY AND THE SITE OF INSERTION WAS AN ARRESTED HEART. THERE WAS NOTHING UNUSUAL ABOUT THE APPENDAGE. THE PATIENT RETURNED TO THE HOSPITAL WITH RAPID ATRIAL FIBRILLATION. A PRE-CARDIOVERSION TEE SHOWED A 2CM RESIDUAL LEFT ATRIAL APPENDAGE (LAA). ANTICOAGULATION WILL HAVE TO BE CONTINUED.

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Additional Manufacturer Narrative

CORRECTION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TRANSESOPHAGEAL ECHOCARDIOGRAM DEMONSTRATED FLOW INTO THE LEFT ATR IAL APPENDAGE AFTER THE LEFT ATRIAL APPENDAGE LIGATION CLIP WAS PLACED. AT THE TIME OF INSERTION, THE CLIP WAS PLACED AND THERE WAS NO FLOW INTO THE LEFT ATRIAL APPENDAGE. THERE WAS NO ISSUE WITH THE PLACEMENT OF THE DEVICE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Additional Manufacturer Narrative

DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWED THE CUSTOMER HAD PROVIDED A CD WITH THE PATIENT DATA. THE REASON FOR THE COMPLAINT WAS UNDETERMINED. CORRECTION B5: IT WAS REPORTED THAT AFTER A SURGERY IN WHICH THE PENDITURE CLIP WAS USED, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED SEVERAL DAYS LATER AND IT WAS OBSERVED THAT THE CLIP HAD SLIPPED OFF, RESULTING IN A 2CM RESIDUAL STUMP. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.