PENDITURE LAA EXCLUSION SYSTEM

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.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A PENDITURE DEVICE, THE SECOND OBTUSE MARGINAL ARTERY (OM2) VEIN GRAFT WAS TORN, ALLEGEDLY FROM RUBBING ON THE CLIP. BLEEDING WAS OBSERVED BY THE SURGEON DURING CLOSURE OF THE PERICARDIUM. EXTRA TIME WAS REQUIRED TO REPAIR THE VEIN GRAFT, WHICH WAS ACCOMPLISHED WITH SEVERAL STITCHES, AND THE BLEEDING SUBSEQUENTLY STOPPED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION B5. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CONCOMITANT PROCEDURE WAS FOR A CORONARY ARTERY BYPASS GRAFTING (CABG) X3. POSTERIOR DESCENDING ARTERY, OM2 AND THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE CLIP WAS NOT DEPLOYED ON A BEATING HEART. A SIZER WAS USED TO DETERMINE THE PENDITURE SIZE. THE IMPLANT TECHNIQUE AND SITE OF INSERTION WAS A TYPICAL INFERIOR APPROACH PER USUAL. THERE WAS NOTHING DIFFERENT ABOUT THE APPENDAGE. THERE WAS NO ISSUE WITH THE APPENDAGE ITSELF, IT WAS THE ROUGHNESS OF THE CLIP AT THE ¿CROTCH¿ AREA WHERE THE HOLES ARE FOR THE PINS TO INSERT. 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

ADDITIONAL INFORMATION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE USER PLACED THE CLIP AFTER THE DISTALS BUT BEFORE THE PROXIMAL. IT WAS NEAR THE OM GRAFT AND THE BLEEDING STARTED AFTER THE HEART WAS RESTARTED. THE PART OF THE CLIP THAT IS AT THE ¿CROTCH¿ SIDE IS ROUGH TO THE TOUCH AND AS IT RUBBED ON THE GRAFT, IT RIPPED IT. CORRECTION B1 (ADV EVNT/PROD): THIS FIELD HAS BEEN UPDATED. CORRECTION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CONCOMITANT PROCEDURE WAS CORONARY ARTERY BYPASS GRAFTING (CABG) OF THE POSTERIOR DESCENDING ARTERY, THE OM2 AND THE LEFT ANTERIOR DESCENDING ARTERY (LAD). CORRECTION SECTION E INITIAL REPORTER STREET 1: THIS FIELD HAS BEEN UPDATED. 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.