PENDITURE LAA EXCLUSION SYSTEM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION B5. THE CLIP WAS NOT USED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT MOVEMENT/SLIPPAGE WAS MORE THAN 10MM. THE SURGEON HAD TO REPOSITION AS WELL AS RECAPTURE A FEW TIMES. THE SURGEON DOES NOT USE A SIZER FOR OUR CLIP OR ANY CLIP FOR THAT MATTER. THIS WAS A CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE. THE SURGEON DID NOT USE ANOTHER CLIP, THE PATIENT LEFT THE OR CLIPLESS. THE CLIP WAS DEPLOYED ON A BEATING HEART WITH HIGH LEFT ATRIAL PRESSURES, NOTHING SPECIAL ABOUT LEFT ATRIAL APPENDAGE (LAA) ANATOMY. INFERIOR APPROACH WAS USED. 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

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 THE PENDITURE CLIP FAILED TO STAY ON THE LEFT ATRIAL APPENDAGE DURING THE PROCEDURE. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

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 1.57 INCHES, THE SPECIFICATION IS 1.59 +/- .04 INCHES. THE JAW TEETH HEIGHT WAS MEASURED TO BE 0.019 AND 0.019 INCHES, THE SPECIFICATION IS 0.020 +/- 0.003 INCHES. THE SHARK FINS OPERATE AS EXPECTED. THE CLAMP FORCE WAS MEASURED TO BE 1.666 LBS., THE SPECIFICATION IS 1.9 +/- 0.6 LBS. REASON FOR THE RETURN WAS UN DETERMINED. ADDITIONAL INFORMATION H6.2 EVAL CODE METHOD (FDM/ANNEX B): THIS FIELD WAS UPDATED. ADDITIONAL INFORMATION H6.3 EVAL CODE RESULT (FDR/ANNEX C): THIS FIELD WAS 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.