BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2558475 · Received May 3, 2012

    Report

    Report Number
    2015691-2012-17412
    Event Type
    Death
    Date Received
    May 3, 2012
    Date of Event
    April 3, 2012
    Report Date
    April 3, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CINE IMAGING REVIEW. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE VALVE WAS PERFORMED AND ALL MANUFACTURER'S SPECIFICATIONS WERE MET PRIOR TO THE RELEASE FOR DISTRIBUTION. CINE IMAGES WERE SUBMITTED TO EDWARDS FOR REVIEW. THE FOLLOWING OBSERVATIONS/IMPRESSIONS WERE MADE: OBSERVATIONS: MODERATE-SEVERE AORTIC VALVE AND ROOT CALCIFICATION, NO PORCELAIN AORTA, NO MITRAL ANNULAR CALCIFICATION (MAC). FAIR COAXIAL ALIGNMENT OF DELIVERY SYSTEM AND GUIDE WIRE. VALVE POSITION CANTED WITH RIGHT CORONARY CUSP (RCC) 60/40 AORTIC, LEFT CORONARY CUSP (LCC) 50/50. VALVE MOVED SLIGHTLY AORTIC DURING DEPLOYMENT. VENTILATION NOT HELD. POST DEPLOYMENT AORTOGRAM DEMONSTRATED AORTIC REGURGITATION (AR). CORONARY ANGIOGRAM PERFORMED ON PUMP WITH HEART ARRESTING DEMONSTRATED A PATENT LIMA GRAFT WITH POOR DISTAL RUN-OFF, HOWEVER, TIMI 3 FLOW. IMPRESSIONS: REFRACTORY HYPOTENSION WITH SUBSEQUENT CARDIAC ARREST POST VALVE DEPLOYMENT MAY BE SECONDARY TO GLOBAL MYOCARDIAL ISCHEMIA, PERICARDIAL TAMPONADE, CARDIAC/AORTIC RUPTURE, SEVERE HYPOVOLEMIA, PULMONARY EMBOLISM, OR OTHER CAUSES (HYPOTHERMIA, ACID-BASE ELECTROLYTE DISORDERS). MYOCARDIAL ISCHEMIA MAY BE ATTRIBUTABLE TO AIR OR PARTICULATE EMBOLI. THIS CANNOT BE EXCLUDED BY CINE; HOWEVER, THE LIMA GRAFT APPEARED PATENT. TAMPONADE DUE TO CARDIAC/AORTIC RUPTURE CANNOT BE EXCLUDED. CONTRAST AORTOGRAPHY WAS INADEQUATE TO RULE OUT AORTIC RUPTURE. CLINICAL CORRELATION IS SOUGHT TO RULE OUT OTHER SOURCES OF MAJOR BLEEDING, PULMONARY EMBOLISM, ETC. NO FURTHER ACTIONS ARE POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST (CS), AT THE END OF THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE PATIENT EXPIRED. CASE SUMMARY: THE FIRST VALVE WAS POSITIONED 60% AORTIC AND 40% VENTRICULAR. A SLOW INFLATION WAS PERFORMED DURING RAPID VENTRICULAR PACING. DURING DEPLOYMENT, THE VALVE MOVED AORTIC AND IN ORDER TO COMPENSATE FOR THE MOVEMENT, THE PHYSICIAN PUSHED THE SYSTEM MORE VENTRICULAR. THE FINAL POSITION OF THE VALVE WAS THOUGHT TO BE OKAY BUT A LITTLE AORTIC. POST DEPLOYMENT PV LEAK WAS ASSESSED VIA TEE WITH A MILD POSTERIOR PV LEAK AND SEVERE MITRAL REGURGITATION (MR) WAS NOTED. THERE WAS ZERO EVIDENCE OF THE NATIVE LEAFLETS OVERHANGING THE SAPIEN VALVE. THE PATIENT'S SYSTOLIC PRESSURE WAS NOTED TO HAVE REMAINED BELOW 90MMHG POST DEPLOYMENT. THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA REQUIRING MULTIPLE DEFIBRILLATION ATTEMPTS AND CPR. AN AORTOGRAM SHOWED NO EVIDENCE OF ANNULAR RUPTURE OR CORONARY OCCLUSION. AFTER MULTIPLE ATTEMPTS, THE PATIENT WAS SUCCESSFULLY CONVERTED AND THE PATIENT'S BLOOD PRESSURE RETURNED BUT REMAINED DEPRESSED. THE DECISION WAS THEN MADE TO DEPLOY A SECOND VALVE MORE VENTRICULAR THAN THE FIRST. DURING DEPLOYMENT, THE VALVE HAD TO BE MANIPULATED MORE VENTRICULAR IN ORDER TO COMPENSATE FOR AORTIC MOVEMENT. POST DEPLOYMENT, CPR WAS CONTINUED. PV LEAK WAS ASSESSED DURING CPR AND NOTED TO BE MILD. AN IABP WAS INSERTED SUCCESSFULLY, HOWEVER, THE PATIENT KEPT GOING INTO V-TACH REQUIRING DEFIBRILLATION. IN THE SHORT AXIS ON ECHO VIEW ALL LEAFLETS WERE SEEN TO BE COAPTING ALTHOUGH THE MR WAS STILL PRESENT. THE PATIENT WAS PLACED ON BYPASS EMERGENTLY AND A CATHETER WAS PLACED ACROSS THE AORTIC VALVE IN AN ATTEMPT TO DECOMPRESS THE VENTRICLE. AT THIS POINT, SEVERE PULMONARY EDEMA WAS NOTED BY ANESTHESIA AND HEMOPTYSIS WAS PRESENT. THE PATIENT DID NOT RESPOND TO RESUSCITATION AND EXPIRED ON THE O.R. TABLE. SELECTIVE CORONARY ANGIOGRAMS WERE PERFORMED REVEALING PATENT ARTERIES AND GRAFTS. ADDITIONAL INFORMATION WAS PROVIDED BY THE EDWARDS CLINICAL SPECIALIST (CS) THAT NOTED THE AUTOPSY REPORT HAD CONFIRMED APPROXIMATELY 5MM OF THE PATIENT'S NATIVE RIGHT LEAFLET WAS OVERHANGING THE SAPIEN FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANSCATHETER HEART VALVE REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 9000TFX23 59177068

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| R