PENDITURE LAA EXCLUSION SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT AFTER SIZING, DURING USE OF A PENDITURE DEVICE, THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES DURING THE OPERATION. HOWEVER, IT WAS NOTED THAT THE TIP OF THE APPLIED CLIP EXTENDED SLIGHTLY DISTALLY TOWARD THE LEFT ATRIAL APPENDAGE. WHILE THE PATIENT'S POSTOPERATIVE CONDITION SHOWED NO ISSUES, THERE WAS A CONCERN RAISED ABOUT POTENTIAL COMPRESSION OF THE LEFT MAIN CORONARY ARTERY. IT WAS COMMUNICATED THAT FURTHER EXAMINATIONS, SUCH AS A CT SCAN, WOULD BE CONDUCTED. DEPENDING ON THE RESULTS OF THE EXAMINATION, THORACOTOMY AGAIN MAY BE PERFORMED TO RECAPTURE THE CLIP AND REPOSITION IT AS NECESSARY. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CONCOMITANT PROCEDURE WAS A PVI (PULMONARY VEIN ISOLATION). THE DEVICE WAS DEPLOYED ON A BEATING HEART. THE IMPLANT TECHNIQUE WAS THE LEFT ATRIAL APPENDAGE CLOSURE VIA THE INFERIOR APPROACH. THERE WAS NOTHING UNUSUAL ABOUT THE APPENDAGE.

Additional Manufacturer Narrative

SECTION E INITIAL REPORTER: THE INITIAL REPORTER'S FIRST AND LAST NAMES AND PHONE NUMBER 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.