BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2962841 · Received February 14, 2013

    Report

    Report Number
    2015691-2013-19287
    Event Type
    Death
    Date Received
    February 14, 2013
    Date of Event
    December 7, 2012
    Report Date
    January 23, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA THE IMPLANT PATIENT REGISTRY, THE PATIENT EXPIRED 17 DAYS S/P TAVR PROCEDURE. THE PATIENT'S MEDICAL RECORDS INDICATE THAT, AT THE TIME OF HIS DEATH THE PATIENT'S DISCHARGE DIAGNOSES WAS CARDIOPULMONARY ARREST, RESPIRATORY FAILURE, ATRIAL FIBRILLATION AND ACUTE RENAL FAILURE. PER THE MEDICAL RECORDS, DURING HIS HOSPITAL COURSE THE PATIENT UNDERWENT A SUCCESSFUL TRANSAPICAL TAVR PROCEDURE AND POST OPERATIVELY SUFFERED FROM RESPIRATORY INSUFFICIENCY AND PACER DEPENDENCE. A PERMANENT PACER WAS IMPLANTED 6 DAYS S/P TAVR. REFER TO 2013-01545 FOR THE INVESTIGATION ON THIS CONDUCTION DEFECT EVENT. POST SAPIEN VALVE DEPLOYMENT THE PATIENT HAD MILD TO MODERATE PVL AND HIS EF WAS 30-35%. THE PATIENT HAD PERSISTENT RESPIRATORY DIFFICULTIES AND 14 DAYS S/P TAVR BRONCHOSCOPY NOTED FOAMY MACROPHAGES CONSISTENT WITH AMIODARONE TOXICITY. HIS RESPIRATORY DIFFICULTIES PERSISTED. AN ECHO IMAGING 9 DAYS S/P TAVR SHOWED MILD PVL AND AN EF OF 30%. AN ECHO PERFORMED 13 DAYS LATER SHOWED MILD TO MODERATE PVL WITH EF 20%. ONE DAY PRIOR TO HIS DEATH, THE PATIENT BEGAN TO SUFFER WORSENING OXYGEN SATURATION AND INCREASED WORK OF BREATHING REQUIRING INTUBATION. UPON INTUBATION THE PATIENT BECAME HYPOTENSIVE AND VOLUME WAS GIVEN. MULTIPLE VASOPRESSORS WERE STARTED AND CPR WAS INITIATED. THERE WAS NO RETURN OF VITAL SIGNS AND THE PATIENT WAS DECLARED DECEASED. THERE ARE MULTIPLE POTENTIAL ETIOLOGIES FOR CARDIOPULMONARY ARREST AND RESPIRATORY FAILURE, INCLUDING, CARDIAC DISEASE, VALVULAR HEART DISEASE, EXACERBATION OF UNDERLYING COPD, VOLUME OVERLOAD, INFECTION/ PNEUMONIA, AND CHF. ANY EPISODE OF RESPIRATORY FAILURE AND/ OR CARDIOPULMONARY ARREST IN THE POSTOPERATIVE PERIOD SUSPECTED TO BE RELATED TO THE BIOPROSTHETIC VALVE WOULD MANDATE AN ECHO REPORT TO EVALUATE THE VALVE FUNCTION. IF THESE EPISODES WERE RELATED TO VALVE DYSFUNCTION, I.E. SEVERE PVL AND/OR CENTRAL LEAK, IT WOULD REQUIRE RE-INTERVENTION. IN THIS CASE, PER ECHO REPORTS, THE VALVE WAS SUCCESSFULLY IMPLANTED AND THE LAST ECHO REPORT PRIOR TO HIS DEATH SHOWED MILD TO MODERATE PVL WITH NO INTERVENTIONS PERFORMED. IT SHOULD BE NOTED THAT THIS PATIENT HAD MULTIPLE SIGNIFICANT CO-MORBIDITIES SUCH AS CAD, CKD SEVERE AORTIC STENOSIS, FRAILTY WITH ADVANCED AGE AND ATRIAL FIBRILLATION. ALL OF THESE FACTORS COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DISCHARGE CONDITIONS AT THE TIME OF HIS DEATH. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING 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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED VIA THE IMPLANT PATIENT REGISTRY, THE PATIENT EXPIRED 17 DAYS S/P TAVR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65793 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26 3090175

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death