BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3130803 · Received May 24, 2013

    Report

    Report Number
    2015691-2013-20173
    Event Type
    Death
    Date Received
    May 24, 2013
    Date of Event
    March 25, 2013
    Report Date
    May 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS WERE REQUESTED TO THE HOSPITAL; HOWEVER, RECEIPT IS NOT EXPECTED FOR APPROXIMATELY 4 WEEKS DUE TO THEIR PROCESSING TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN NEW INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    PER THE TRANSAPICAL TAVR PROCEDURE OPERATIVE NOTE AND DISCHARGE SUMMARY: THE PATIENT¿S AORTIC ANNULUS DIAMETER MEASURED 21-22MM BY TEE AND 22MM BY CT. BAV WAS PERFORMED WITH A 23MM X 4CM BALLOON. NEXT THE PREPPED 26MM SAPIEN VALVE WAS POSITIONED ACROSS THE AORTIC VALVE AND OPTIMAL POSITION WAS CONFIRMED DURING RAPID VENTRICULAR PACING (RVP) AND SIMULTANEOUS AORTOGRAPHY. ON THE FINAL RVP RUN, THE VALVE WAS DEPLOYED. POST DEPLOYMENT TEE REVEALED GOOD VALVE POSITION/FUNCTION WITH NO COMPLICATIONS. POST DEPLOYMENT THE VALVE HAD TRACE PARAVALVULAR AI AND TRACE CENTRAL AI. THE BIOPROSTHETIC VALVE WAS NOTED TO BE IN GOOD POSITION WITH MEAN GRADIENT OF 3. THERE WAS MILDLY IMPROVED LV FUNCTION FROM BASELINE TO EF OF 50-55%. AFTER ACCESS SITE CLOSURE, THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS. THE PATIENT PRESENTED TO THE CICU POSTOPERATIVELY ALREADY EXTUBATED AND WAS PROGRESSED TO PO BLOOD PRESSURE CONTROL. TWO DAYS AFTER TAVR, THE PATIENT DEVELOPED ATRIAL FIBRILLATION AND WAS LOADED WITH AMIODARONE. ALSO OVER THE COURSE OF RECOVERY, THE PATIENT DEVELOPED AN ILEUS WHICH REMAINED RESISTANT TO MULTIPLE THERAPIES. AN OG TUBE WAS PLACED AND REMOVED MULTIPLE TIMES FOR GASTRIC DECOMPRESSION. FIVE DAYS AFTER TAVR THE PATIENT EXHIBITED A SUDDEN DECREASE IN OXYGEN SATURATION FOLLOWED BY AN INCREASED WORK OF BREATHING. THE PATIENT PROCEEDED TO GO INTO RESPIRATORY FAILURE AND WAS IMMEDIATELY INTUBATED. THIS WAS FOLLOWED BY EPISODES OF BRADYCARDIA AND HYPOTENSION RESISTANT TO MULTIPLE THERAPIES OVER THE COURSE OF 2 HOURS. INTERMITTENT EPISODES OF CARDIAC ARREST ALSO EVENTUALLY BECAME UNRESPONSIVE TO MULTIPLE THERAPIES GIVEN INCLUDING INOTROPIC SUPPORT. AFTER DISCUSSING THE PATIENT¿S DETERIORATION WITH THE FAMILY IT WAS DECIDED TO STOP THE RESUSCITATIVE EFFORTS AND THE PATIENT PASSED AWAY. PER THE INSTRUCTIONS FOR USE (IFU), DEATH IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE OVERALL TAVR PROCEDURE, INCLUDING VASCULAR AND APICAL ACCESS, USE OF ANGIOGRAPHY, BALLOON VALVULOPLASTY, USE OF CONSCIOUS SEDATION AND/OR GENERAL ANESTHESIA, AND THE BIO-PROSTHESIS IMPLANTATION. THERE ARE MULTIPLE POTENTIAL ETIOLOGIES FOR RESPIRATORY FAILURE, INCLUDING EXACERBATION OF UNDERLYING COPD, VOLUME OVERLOAD, INFECTION/ PNEUMONIA, AND CHF. THE IMMEDIATE CAUSE OF SUDDEN CARDIAC ARREST IS USUALLY AN ABNORMAL HEART RHYTHM (ARRHYTHMIA). SOME OTHER HEART CONDITIONS THAT CAN LEAD TO SUDDEN CARDIAC ARREST INCLUDE CAD, MI, CARDIOMYOPATHY, VALVULAR HEART DISEASE, AND CONGENITAL HEART DISEASE. FACTORS THAT INCREASE A PATIENT¿S RISK OF CARDIAC ARREST INCLUDE SMOKING, ADVANCED AGE, GENDER, HYPERTENSION, LOW BLOOD PRESSURE, OBESITY, DIABETES, A SEDENTARY LIFESTYLE, A HISTORY OF ARRHYTHMIA, AND NUTRITIONAL IMBALANCES. IN THIS CASE, THE PATIENT SUDDENLY DEVELOPED RESPIRATORY FAILURE (SUDDEN DECREASE IN OXYGEN SATURATION WITH INCREASED WORK OF BREATHING) AND HIS CONDITION RAPIDLY DETERIORATED OVER THE FOLLOWING HOURS DESPITE TREATMENT UNTIL THE RESUSCITATIVE EFFORTS WERE FINALLY WITHDRAWN AND HE DIED. THE CAUSE OF THE INITIAL RESPIRATORY FAILURE WAS NOT DETERMINED; HOWEVER, IT IS POSSIBLE THAT THE PATIENT¿S HIGH RISK PROFILE AND SIGNIFICANT UNDERLYING CO-MORBIDITIES MAY HAVE CONTRIBUTED TO THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION, AND THERE IS NO INDICATION THAT AN AUTOPSY WAS PERFORMED. THERE IS NO EVIDENCE OR SUGGESTION OF A DEVICE MALFUNCTION. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES WAS NOTIFIED THROUGH THE IPR DEPARTMENT THAT THE PATIENT PASSED AWAY 6 DAYS AFTER THE IMPLANT OF A SAPIEN VALVE. ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232379 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death