BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 3771507 · Received April 24, 2014

    Report

    Report Number
    2024168-2014-02585
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO ASSOCIATED NON-CONFORMANCES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY THE 2.75 X 38 MM MULTILINK 8 STENT DELIVERY SYSTEM (SDS) WAS OPENED AND REMOVED FROM THE PROTECTIVE PLASTIC COIL WHEN FOREIGN MATERIAL LIKE A HAIR WAS NOTED ON THE STENT IMPLANT. THE DEVICE WAS NOT USED; THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248992 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2031441

    Patients

    Seq Age Sex Outcome Treatment
    1