BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 3800908 · Received May 8, 2014

    Report

    Report Number
    2024168-2014-02947
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 14, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 INCIDENTS FOR STENT DISLODGMENT 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 DEVICE PREPARATION AND PRIOR TO USE THE 2.5 X 23 MM MULTI-LINK 8 STENT IMPLANT WAS DISLODGED. 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
    277344 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2070541

    Patients

    Seq Age Sex Outcome Treatment
    1