BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2943898 · Received February 5, 2013

    Report

    Report Number
    2015691-2013-19194
    Event Type
    Death
    Date Received
    February 5, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 11, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED INDICATED THAT ONE DAY POST TAVR THE PATIENT WAS DIAGNOSED WITH A LEFT HEMISPHERIC STROKE AND THE HEAD CT CONFIRMED A LEFT PREFRONTAL GYRUS INFARCT. ADDITIONALLY A CT ANGIO SHOWED A TYPE B AORTIC DISSECTION AND TOTAL HEART BLOCK WITH SINUS PAUSES OCCURRED DURING THE TAVR PROCEDURE. THE PATIENT WAS SUBSEQUENTLY IMPLANTED WITH A PERMANENT PACEMAKER 2 DAYS LATER. HOWEVER, THE PATIENT CONTINUED TO DETERIORATE AND THE FAMILY DECIDED TO PROCEED WITH COMFORT MEASURES ONLY AND THE PATIENT PASSED AWAY 10 DAYS POST TAVR. THE OFFICIAL CAUSE OF DEATH WAS ISCHEMIC CEREBRAL VASCULAR ACCIDENT. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURY, INCLUDING PERFORATION OR DISSECTION OF VESSELS WHICH MAY REQUIRE INTERVENTION, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. ACCORDING TO THE THV TRAINING MANUAL, RISK FACTORS FOR ACUTE AORTIC RUPTURE/DISSECTION IN THE TAVR PROCEDURE INCLUDE SIGNIFICANT VALVE OVER SIZING (I.E. =4MM) IN THE PRESENCE OF SEVERELY CALCIFIED AORTIC ROOT AND OBLITERATED SINUSES. WHILE THE SAPIEN HEART VALVE RELIES ON NATIVE VALVE CALCIUM TO SECURELY ANCHOR TO THE ANNULUS, DESPITE THIS BENEFICIAL ASPECT OF CALCIUM, BULKY CALCIUM CAN INCREASE THE RISK OF CALCIFIC NODULE DISPLACEMENT INTO THE VASCULATURE WHICH CAN LEAD TO VASCULAR INJURY. AT TIMES THE EXTENT AND DISTRIBUTION OF CALCIUM CAN IMPAIR EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE AND PROCEDURAL SUCCESS. PER THE INSTRUCTIONS FOR USE FOR THE EDWARDS SAPIEN VALVE, PERMANENT OR TRANSIENT NEUROLOGICAL EVENTS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. MAJOR RISK FACTORS FOR TIA AND STROKE INCLUDE HTN, ATRIAL FIBRILLATION, DIABETES, FAMILY HISTORY OF STROKE, HIGH CHOLESTEROL, INCREASING AGE, AND RACE. IN THIS CASE THE EXACT CAUSES FOR THE EVENTS ARE UNKNOWN, HOWEVER, IN ADDITION TO THE PROCEDURE ITSELF THERE ARE MULTIPLE POTENTIAL CO-MORBIDITIES INCLUDING SEVERE AORTIC STENOSIS, DIABETES, AND ADVANCED AGE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENTS. SINCE THERE IS NO LABELING ISSUES AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. 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 PREVENTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE VALVE WAS NOT PERFORMED/REQUIRED AS THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION. INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 1

    AS REPORTED THROUGH THE (B)(6), TEN DAYS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48672 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 59103340

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| R