BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 2910473 · Received January 11, 2013

    Report

    Report Number
    2024168-2013-00225
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL, RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MILDLY TORTUOUS/CALCIFIED MID CIRCUMFLEX ARTERY, PRE-DILATATION WAS PERFORMED, FOLLOWED BY ADVANCEMENT OF A 2.5X23 RX MULTI-LINK 8 STENT SYSTEM. WHILE ADVANCING THE STENT SYSTEM THROUGH THE LESION, MILD RESISTANCE WAS FELT AND NO ADDITIONAL FORCE WAS APPLIED; HOWEVER, THE PROXIMAL SHAFT SEPARATED OUTSIDE OF THE PATIENT ANATOMY APPROXIMATELY AT THE LOCATION WHERE THE PHYSICIAN WAS HOLDING THE STENT SYSTEM. THE STENT SYSTEM WAS WITHDRAWN FROM THE ANATOMY AND A NON-ABBOTT STENT SYSTEM WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16472 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2020141

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR