BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 3022126 · Received March 26, 2013

    Report

    Report Number
    2024168-2013-01743
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 24, 2013
    Report Date
    March 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED. BASED ON ANALYSIS OF THE RETURNED STENT, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE UNPACKING AND PRIOR TO USE, THE 3.5 X 12 MM MULTI-LINK 8 STENT IMPLANT WAS FOUND TO BE DISLODGED FROM THE BALLOON. IT WAS NOTED THE PROTECTIVE SHEATH HAD BEEN REMOVED FROM THE DEVICE WITHOUT ANY RESISTANCE NOTED. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123518 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 3011741

    Patients

    Seq Age Sex Outcome Treatment
    1