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 CLIP INITIALLY HELD ON THE APPENDAGE BUT MIGRATED AFTER AT LEAST AN HOUR. THE BACK OF THE CLIP MOVED APPROXIMATELY 1.5 CM, AND THE FRONT MOVED ABOUT 0.5 CM. THE CLIP WAS REDEPLOYED, BUT IT MOVED AGAIN IN A SIMILAR MANNER. THE PATIENT WAS ON PUMP, CLAMPED, AND CARDIOPLEGIA WAS ADMINISTERED, WITH THE HEART DECOMPRESSED. THE CLIP WAS EVENTUALLY REMOVED AND REPLACED WITH A 45 MILLIMETER FLEX V FROM ANOTHER MANUFACTURER, WHICH DID NOT MOVE. THE PRODUCT WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER USED THE SIZER TO CONFIRM THE CLIP SIZE. THE CUSTOMER HAS DONE CLOSE TO 100 PENDITURE CASES SUCCESSFULLY. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT AN OPEN SURGICAL APPROACH WAS USED. THIS WAS A CORONARY ARTERY BYPASS GRAFT (CABG). MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE WAS MOVED WHILE THE PATIENT WAS ON PUMP, JUST AFTER THE CROSS CLAMP WAS PLACED.