PENDITURE LAA EXCLUSION SYSTEM

Additional Manufacturer Narrative

SECTION E INITIAL REPORTER: THE FIRST AND LAST NAMES AND PHONE NUMBER OF THE INITIAL REPORT ARE NOT AVAILABLE DUE TO REGIONAL PRIVACY LAWS. 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

MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PENDITURE CLIP DEIVCE, IT WAS REPORTED THAT THE CLIP PORTION METAL FITTING WAS WEAK AND COULD NOT BE CLIPPED PROPERLY. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENTS EFFECTS. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CLIP FELL OFF AND COULD NOT BE PLACED PROPERLY. THE CONCOMITANT PROCEDURE IS MVP. IT WAS NOT DEPLOYED ON A BEATING HEART, THE IMPLANT TECHNIQUE AND SITE OF INSERTION ARE UNKNOWN, BUT THERE WAS NOTHING UNUSUAL ABOUT THE ATRIAL APPENDAGE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT MVP REFERS TO MITRAL VALVE PLASTY. THE CUSTOMER DID NOT NEED TO RE-CAPTURE AND RE-DEPLOY THE DEVICE DURING INITIAL PLACEMENT. A SIZER WAS USED TO DETERMINE THE PENDITURE SIZE. THE REPLACEMENT DEVICE WAS PENDITURE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER STATED THAT THE CLIP FELT WEAKER ALTHOUGH IT WAS THE SAME 45MM SIZE.

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

DEVICE EVALUATION: VISUAL INSPECTION SHOWS NO OUTWARD SIGNS OF ANY DAMAGE. THE CLIP DIMENSIONS WERE MEASURED TO BE AS FOLLOWS. CLIP FORCE WAS PERFORMED. CLIP LENGTH WAS MEASURED TO BE 1.76, THE SPECIFICATION IS 1.77 +/- .04 INCHES THE JAW TEETH HEIGHT WAS MEASURED TO BE 0.019 AND 0.020 INCHES, THE SPECIFICATION IS 0.020 +/- 0.003 INCHES THE SHARK FINS OPERATE AS EXPECTED. THE CLAMP FORCE WAS MEASURED 2 TIMES, 2.026 AND 1.930 LBS., THE SPECIFICATION IS 1.9 +/- 0.6 LBS. CONCLUSION: 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. THE DEVICE WAS REPLACED WITH AN MDT DEVICE TO COMPLETE THE PROCEDURE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CLIP DID NOT FALL OFF THE HEART OR THE DELIVERY SYSTEM. THE ISSUE OCCURRED DURING CLIP DEPLOYMENT. THE DEVICE DID NOT MOVE AFTER THEY PLACED IT ON THE HEART. 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.