BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2862449 · Received December 10, 2012

    Report

    Report Number
    2015691-2012-18789
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    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

    ADDITIONAL INFORMATION PROVIDED BY THE EDWARDS CLINICAL SPECIALIST (CS), INDICATED THE PATIENT'S IS CURRENTLY IN AN EXTENDED CARE FACILITY (ECF) AND IS DOING POORLY. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED OR PERFORMED AS THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION. 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 CAUSE FOR THE EVENT IS UNKNOWN, HOWEVER, ALONG WITH THE PROCEDURE ITSELF, THERE ARE MULTIPLE POTENTIAL FACTORS INCLUDING THE PATIENT'S CO-MORBIDITIES (I.E. DIABETES) AND INCREASING AGE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. 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

    INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, ONE DAY POST TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE PATIENT SUFFERED A MASSIVE STROKE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other