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 DEPLOYMENT OF THE PENDITURE DEVICE, THE SURGEON FELT THE CLIP WAS SLIPPING OFF THE PROXIMAL END. THE DEVICE WAS NEVER IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CONCOMITANT PROCEDURE WAS A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE. A SIZER WAS USED TO DETERMINE THE PENDITURE SIZE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SURGEON DID NOT FIRE THE CLIP AS IT STAYED ON THE HANDLE THE ENTIRE TIME. THE CLIP REMAINED ON THE HOLDER THE ENTIRE TIME. IT WAS NOTED THAT AT THE PROXIMAL TIP OF THE CLIP THAT IT SLIPPED ¿A FEW MILIMETERS¿ HOWEVER THE CLIP WAS NOT REMOVED FROM THE HANDLE AND IT CANNOT BE DETERMINED IF THAT PLAYED A ROLE OR NOT. THE CLIP WAS NOT DEPLOYED ON A BEATING HEART. THE IMPLANT TECHNIQUE AND SITE OF INSERTION WAS INFERIOR. THERE WAS NOTHING UNUSUAL ABOUT THE APPENDAGE. DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS NO OUTWARD SIGNS OF ANY DAMAGE. THE CLIP DIMENSIONS WERE MEASURED TO BE AS FOLLOWS. CLIP LENGTH WAS MEASURED TO BE WITHIN SPECIFICATION. THE JAW TEETH HEIGHT WAS MEASURED TO BE WITHIN SPECIFICATION. THE SHARK FINS OPERATE AS EXPECTED. THE CLAMP FORCE WAS MEASURED TO BE WITHIN SPECIFICATION. REASON FOR RETURN WAS UNDETERMINED. 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 CLIP WAS CLOSED ON THE APPENDAGE, SO IT WAS IN DIRECT CONTACT WHEN THE ¿SLIP¿ OCCURRED. HOWEVER, THE DEVICE ITSELF WAS NOT COMPLETELY DEPLOYED. THE USER'S HAND WAS OFF THE HANDLE, SO THE DEVICE WAS COMPLETELY CLOSED. THE SLIP NOTICED WAS AT THE PROXIMAL END OF THE CLIP ON THE APPENDAGE ITSELF. THE USER ESTIMATED "A FEW MILLIMETERS". AS THE DEVICE WAS NOT COMPLETELY DEPLOYED, ANY TENSION ON THE HANDLE COULD HAVE IMPACTED ANY SORT OF SLIPPAGE. CORRECTION D4.2 (EXPIRATION DATE) 4.5 (UNIQUE IDENTIFIER (UDI) #): THESE FIELDS HAVE BEEN UPDATED. CORRECTION H4 (DEVICE MFG DATE): 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.