BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 11083316 · Received December 28, 2020

    Report

    Report Number
    2015691-2020-15303
    Event Type
    Injury
    Date Received
    December 28, 2020
    Date of Event
    December 1, 2020
    Report Date
    November 13, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HONG, N. C., ET AL. ''TRANSCATHETER AORTIC VALVE REPLACEMENT WITH ANTEROGRADE GUIDE WIRE THROUGH ATRIAL SEPTUM IN 2 PATIENTS WITH SEVERE AORTIC STENOSIS POST TRANSCATHETER OR SURGICAL AORTIC VALVE REPLACEMENT.'' ZHONGHUA XIN XUE GUAN BING ZA ZHI 50.5 (2022): 509-511. CORRECTED B.7 AND D6A BASED ON INFORMATION DISCOVERED IN THE ARTICLE REFERENCED ABOVE.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4); INVESTIGATION IS ONGOING. THIS INDIVIDUAL REPORT PROVIDES DATA RECEIVED FROM THE THV/TVT REGISTRY.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS EUROPEAN AFFILIATE, 10 MONTHS AFTER IMPLANTATION OF A 20MM SAPIEN 3 VALVE, THE PATIENT BEGAN TO SUFFER FROM SEVERE ANGINA. CARDIAC ECHOCARDIOGRAPHY SHOWED AOV PEAK VELOCITY 430 CM/S, AOV PEAK GRADIENT 74 MMHG AND AOV MEAN GRADIENT OF 39 MMHG. PATIENT WAS HOSPITALIZED DUE TO CHEST PAIN. TREATMENT INVOLVED ANTICOAGULATION THERAPY, AS PHYSICIAN SUSPECTS VALVE THROMBOSIS AS ROOT CAUSE OF AORTIC VALVE STENOSIS. A VIV PROCEDURE WAS PERFORMED WITH A SELF-EXPANDABLE NON-EDWARDS VALVE. THROMBOSIS WAS CONFIRMED AS THE ROOT CAUSE AND THE PATIENT WAS IN GOOD CONDITION AND STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549382 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX20 5731788

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Hospitalization| R