BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANCATHETER HEART VALVE RETROFLEX 3 DELIVERY SYSTEM

    MDR report key: 2778421 · Received October 9, 2012

    Report

    Report Number
    2015691-2012-18429
    Event Type
    Death
    Date Received
    October 9, 2012
    Date of Event
    May 24, 2012
    Report Date
    August 2, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS NOT EXPLANTED AFTER THE PATIENT¿S DEMISE; HOWEVER, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURY INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES THAT MAY REQUIRE INTERVENTION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL VALVE REPLACEMENT PROCEDURE. PER THE SAPIEN PATIENT SCREENING MANUAL, THIS PRODUCT IS CONTRAINDICATED FOR TRANSFEMORAL USE IN PATIENTS WHO HAVE SIGNIFICANT AORTIC TORTUOSITY OR DISEASE INCLUDING ABDOMINAL OR THORACIC ANEURYSM. THE EXACT CAUSE OF THE DESCENDING THORACIC AORTIC DISSECTION REPORTED IN THIS CASE CANNOT BE CONFIRMED. HOWEVER, PER THE AVAILABLE INFORMATION, IT IS POSSIBLE THAT THE PATIENT'S SEVERELY TORTUOUS DESCENDING AORTA MAY HAVE CONTRIBUTED TO THE EVENT. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE, AND ALL OF THE TAVR DEVICES WERE DESCRIBED AS WORKING EFFECTIVELY. 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. 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 PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED ON A RETURNED IMPLANT PATIENT REGISTRY CARD, THE PATIENT EXPIRED. AFTER THE INITIAL REPORT, THE MEDICAL RECORDS PERTAINING TO THIS PATIENT'S DEATH WERE OBTAINED. PER THE MEDICAL RECORDS, THE PATIENT EXPIRED DUE TO A PRESUMED COMPLICATION OF THE TAVR PROCEDURE. ACCORDING TO THE OPERATING PHYSICIAN, THE TAVR PROCEDURE WAS DESCRIBED AS UNEVENTFUL. THE SAPIEN VALVE WAS DEPLOYED WITHOUT DIFFICULTY IN AN EXCELLENT POSITION, WITH MILD PERIOPERATIVE INSUFFICIENCY AND EXCELLENT VALVE OPENING. HOWEVER, THAT EVENING, THE PATIENT DEVELOPED SUDDEN CHEST-TO-BACK PAIN, WHICH RESOLVED WITH MORPHINE. A CT SCAN REVEALED A LIMITED AORTIC DISSECTION IN THE DESCENDING THORACIC AORTA, EXTENDING FROM JUST DISTAL TO THE LEFT SUBCLAVIAN. THERE WAS NO BRANCH OR LUMINAL COMPROMISE, AND THE PATIENT STABILIZED WITHOUT ANY HEMODYNAMIC COMPROMISE. HOWEVER, SHORTLY THEREAFTER, THE PATIENT DEVELOPED A SECOND EPISODE OF PAIN AND CARDIAC ARRESTED. HE BECAME UNRESPONSIVE WITH MARKED SINUS BRADYCARDIA AND ASYSTOLE. THE PATIENT SUBSEQUENTLY EXPIRED. PER THE ATTENDING PHYSICIAN, IT IS PRESUMED THAT THE PATIENT EXPIRED AS A CONSEQUENCE OF THE AORTIC DISSECTION. OF NOTE, THE PATIENT HAD A SEVERELY TORTUOUS DESCENDING THORACIC AORTA, WHICH NONETHELESS DID NOT IMPEDE CATHETER ADVANCEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANCATHETER HEART VALVE RETROFLEX 3 DELIVERY SYSTEM TRANSCATHETER HEART VALVE DELIVERY SYSTEM LWR EDWARDS LIFESCIENCES 9120FS23

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death