PENDITURE LEFT ATRIAL APPENDAGE EXCLUSION CLIP

Description of Event or Problem

MEDTRONIC'S RECENTLY LAUNCHED PENDITURE CLIP DEVICE FOR LEFT ATRIAL APPENDAGE EXCLUSION (LAAE) IN CARDIAC SURGERY PROCEDURES IS DANGEROUS AND POSING SERIOUS RISKS TO PATIENT HEALTH & SAFETY. SINCE THE PRODUCT WAS LAUNCHED, THE ADVERSE EVENT REPORTS ON THE FOUR AVAILABLE SIZES OF THE PENDITURE DEVICE (35-50MM, P/N'S LAAC35-50) ARE BUILDING UP RAPIDLY IN THE FDA MAUDE DATABASE AND NOW PATIENT DEATHS ARE ALSO BEING REPORTED THAT ARE POSSIBLY ATTRIBUTED TO THE DEVICE. MEDTRONIC ONLY TESTED THE DEVICE IN DOGS PRIOR TO 510(K) APPROVAL THEN MOVED DIRECTLY & RAPIDLY TO GLOBAL COMMERCIALIZATION AND A HIGH-PRESSURE SALES LAUNCH SUCH THAT THE COMPANY COULD BEGIN RECUPERATING ON ITS INVESTMENT ASAP. IN ESSENCE, THE FIRST REAL CLINICAL TRIAL OF THE PENDITURE DEVICE IN HUMANS IS OCCURRING POST-COMMERCIALIZATION. ADVERSE EVENTS ARE STACKING UP IN THE MAUDE DATABASE THAT SHOULD BE FURTHER INVESTIGATED BY THE FDA AND THIS PRODUCT SHOULD BE RECALLED FROM THE MARKET BEFORE IT HARMS MORE PATIENTS. THERE ARE MULTIPLE REPORTS NOW OF BLEEDING ASSOCIATED WITH THIS PENDITURE DEVICE AS WELL AS THE CLIP SLIPPING ON THE APPENDAGE POST IMPLANT. SLIPPING OF THE CLIP CAN RESULT IN A RESIDUAL STUB/POCKET IN THE APPENDAGE WHERE CLOTS COULD STILL FORM IN PATIENTS WITH AFIB THAT COULD BREAK FREE AND RESULT IN AN ISCHEMIC STROKE. THERE HAS ALSO BEEN A PATIENT DEATH NOW. THE PENDITURE CLIP ITSELF, DOES NOT HAVE ANY KIND OF PROTECTIVE FABRIC COATING LIKE OTHER COMPETITIVE LAA CLIPS ON THE MARKET (EX. ATRICURE ATRICLIP). THE HARD, PEEK POLYMER COMPOSITION OF THE PENDITURE DEVICE IS EXPOSED DIRECTLY TO THE FRAGILE EXTERIOR TISSUE OF THE BEATING HUMAN HEART. THE CLIP ALSO HAS SHARP/ROUGH EDGES ON THE BACKSIDE WHERE THE PINS FROM THE DEPLOYMENT DEVICE INSERT INTO THE CLIP (PLEASE SEE ATTACHED PICTURE). THESE EDGES ARE VERY THIN AND CAN ACT AS A SORT OF CERAMIC KNIFE TYPE EDGE THAT COULD POTENTIALLY BE DRIVEN INTO THE HEART WALL POST IMPLANT AND RESULT IN ABRASIONS & BLEEDING WHICH THERE ARE MULTIPLE REPORTS OF NOW IN THE FDA MAUDE DATABASE. ONE OF THE MAIN CORONARY ARTERIES OF THE HEART, THE CIRCUMFLEX ARTERY, ALSO RUNS ALONG THE BASE OF THE APPENDAGE EXACTLY WHERE LAAE CLIPS ARE SUPPOSED TO BE IMPLANTED BY THE SURGEON. THE CURRENT DESIGN OF THE PENDITURE DEVICE WITH IT'S ROUGH/SHARP EDGES POSES A MAJOR PATIENT SAFETY RISK AS FAR AS POTENTIALLY CUTTING DIRECTLY INTO THE CIRCUMFLEX ARTERY WHICH COULD LEAD TO FATAL OUTCOMES FOR PATIENTS. PATIENT: 1888,1689. DEVICE: 1506, 4013, 1544. REFERENCE REPORTS: MW5174085, MW5174086, MW5174088.