BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3041639 · Received April 8, 2013

    Report

    Report Number
    2015691-2013-19771
    Event Type
    Death
    Date Received
    April 8, 2013
    Date of Event
    March 17, 2012
    Report Date
    March 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE MANUFACTURER REPORT NO. 2015691-2013-19745. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THERE IS NO RECORD OF IT BEING EXPLANTED AFTER THE PATIENT'S DEMISE AND THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE, HYPOTENSION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY (BAV), THE USE OF ANESTHESIA, AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. THE MOST COMMON ETIOLOGIES FOR HYPOTENSION ARE DEHYDRATION, MODERATE TO SEVERE BLEEDING, SEVERE ORGAN INFLAMMATION, UNDERLYING HEART DISEASE, PULMONARY EMBOLISM, ABNORMAL HEART RHYTHMS, AND CERTAIN MEDICATIONS. THESE PATIENTS TYPICALLY ARE NON-OPERATIVE AND/OR EXTREMELY HIGH RISK AND HAVE COMPLEX MEDICAL HISTORIES AND MULTIPLE CO-MORBIDITIES. IN ADDITION, THEY ARE ROUTINELY ADMINISTERED MULTIPLE VASOACTIVE DRUGS DURING THE PROCEDURE. THEY ARE ALSO PURPOSELY MADE HYPOTENSIVE, UTILIZING EXTREME TACHYCARDIA (BY MEANS OF RAPID VENTRICULAR PACING), TO FACILITATE ACCURATE VALVE DEPLOYMENT. IN THIS CASE, THE ETIOLOGY OF THE REPORTED MULTIPLE ORGAN FAILURE CANNOT BE CONFIRMED; HOWEVER, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION OR REPORT OF DEVICE REGURGITATION. THE COMPLEX AORTIC AND MITRAL TRANSCATHETER VALVE REPLACEMENT PROCEDURE IN COMBINATION WITH THE PATIENT'S UNDERLYING SIGNIFICANT COMORBIDITIES (I.E. CHF, TR, AS, MR,CAD, ADVANCED AGE) AND COMPLICATED POST-OPERATIVE COURSE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. 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 MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    EDWARDS WAS NOTIFIED POST-OPERATIVELY AFTER A TRANSCATHETER AORTIC AND MITRAL VALVE REPLACEMENT VIA TRANSAPICAL APPROACH THE PATIENT CONTINUED TO DO POORLY REQUIRING ONGOING VASOPRESSOR SUPPORT . THE PATIENT DEVELOPED MULTI-ORGAN FAILURE AND EXPIRED 41 DAYS AFTER THE INDEX TAVR PROCEDURE. PER THE OP REPORT, AFTER BAV OF THE NATIVE AORTIC VALVE A 23MM SAPIEN VALVE WAS DEPLOYED WITH GOOD RESULT. THE WIRE WAS THEN MOVED ACROSS THE SURGICAL MITRAL VALVE AND A 26MM SAPIEN VALVE WAS IMPLANTED IN THE MITRAL POSITION UNDER RVP. PER REPORT BOTH VALVES WERE WELL SEATED. THE SHEATH WAS REMOVED AND HEMOSTASIS WAS ASSURED AND THE LV APEX WAS CLOSED IN THE USUAL MANNER. THE MAJOR POSTOPERATIVE COMPLICATIONS REPORTED IN THE MEDICAL RECORDS INCLUDED ACUTE RESPIRATORY FAILURE REQUIRING RE-INTUBATION DUE TO HYPOXIA WITH EVENTUAL TRACHEOSTOMY, HYPOTENSION, RIGHT VENTRICLE MODERATE CARDIAC INSUFFICIENCY IN THE SETTING OF PULMONARY HYPERTENSION WITH 3+ TR, ACUTE DELIRIUM, STRESS HYPERGLYCEMIA, ACUTE ON CHRONIC RENAL FAILURE REQUIRING DIALYSIS, LFT ELEVATION, FUNGEMIA, LEUKOCYTOSIS, AND POST OP ILEUS WITH ELEVATED LACTATE PROGRESSING TO A DIAGNOSIS AND SURGERY FOR ISCHEMIC BOWEL. ADDITIONALLY, THERE WAS AN LV PSEUDOANEURYSM NOTED AFTER THE TRACHEOSTOMY SURGERY. THE CRITICAL NATURE OF THE PATIENT'S ILLNESS WAS RE-EXPLAINED TO THE FAMILY. WITH THE FAMILY'S AGREEMENT, COMFORT CARE WAS INSTITUTED. THE PATIENT EXPIRED IN THE ICU LATER THAT EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143901 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death