BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RP ENDOPROSTHESIS

    MDR report key: 16771578 · Received April 19, 2023

    Report

    Report Number
    2124215-2023-16900
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 24, 2023
    Report Date
    April 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    UDI-DI
    08714729406495
    PMA / PMN Number
    K152842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2 AGE AT TIME OF EVENT: 18 YEARS OLD OR OLDER. G4: PREMARKET / 510(K) #: ADDITIONAL #S: K152853, P930031, P980033.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS SHUNT. A 10X94X75/ 7F WALLSTENT RP ENDOPROSTHESIS WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING DEPLOYMENT, THE STENT HARDLY DEPLOYED INSIDE THE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373804 WALLSTENT RP ENDOPROSTHESIS PROSTHESIS, TRACHEAL, EXPANDABLE MAF BOSTON SCIENTIFIC CORPORATION 26265 0028362388 08714729406495

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown