PENDITURE LAA EXCLUSION SYSTEM

Additional Manufacturer Narrative

DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS THE CLIP HAS BEEN OVER ROTATED WITH THE CLIP ORIENTATION POINTING DOWN. ADDITIONAL VISUAL INSPECTION SHOWS EVIDENCE OF DAMAGE TO THE HANDLE HOUSING CONNECTION BY THE SHAFT AREA. THE DEVICE WAS CUT APART AND THERE IS EVIDENCE OF DAMAGE TO THE COLLAR THAT ALLOWS THE SHAFT TO ROTATE. REASON FOR THE RETURN WAS CONFIRMED. 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

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

IT WAS REPORTED THAT DURING USE OF A PENDITURE CLIP DEVICE, WHEN THE KNOB WAS TURNED TO ADJUST THE ANGLE, IT COULD NOT BE FIXATED DUE TO IDLING. THE DEVICE WAS REPLACED WITH A DIFFERENT SIZE (LAAC40). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PROCEDURE WAS ISOLATED LEFT ATRIAL APPENDAGE CLOSURE FOR ATRIAL FIBRILLATION ONLY. THE CLIP WAS DEPLOYED ON A BEATING HEART WITHOUT USING OF A HEART-LUNG MACHINE. LEFT ATRIAL APPENDAGE CLOSURE (LAAC) FROM THE LEFT SIXTH INTERCOSTAL UNDER DIRECT VIEW AND ENDOSCOPIC. SINCE THE TIP OF THE LEFT ATRIAL APPENDAGE WAS WIDELY SPREAD OUT IN A CAULIFLOWER SHAPE, A PENDITURE WAS CHOSEN THAT COULD BE PINCHED FROM THE SIDE OF THE BASE WITHOUT INTERFERING WITH THE TOP. THEREWAS NO TISSUE DAMAGE. THROMBOSIS DID NOT OCCUR. THERE WAS NO PATIENT BLOOD LOSS.