BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 5279189 · Received December 9, 2015

    Report

    Report Number
    2024168-2015-07411
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    November 16, 2015
    Report Date
    December 9, 2015
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT PRODUCTS: DILATATION CATHETER: TREK 2.5X20MM. GUIDE WIRE: FIELDER FC. (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. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MID CIRCUMFLEX CORONARY ARTERY, WHICH WAS 80% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED. THE LESION WAS ACCESSED WITH A NON-ABBOTT GUIDE WIRE AND PRE-DILATED WITH A 2.5X20MM TREK BALLOON DILATATION CATHETER. SEVERAL ATTEMPTS WERE MADE TO CROSS THE LESION WITH A 3.0X38MM MULTI-LINK 8 STENT DELIVERY SYSTEM (SDS), BUT RESISTANCE WITH THE ANATOMY PREVENTED CROSSING. FORCE WAS APPLIED AND THE SHAFT KINKED. THE SDS WAS WITHDRAWN SMOOTHLY, BUT A PROXIMAL SHAFT SEPARATION OCCURRED. THE DISTAL PORTION OF THE SDS WAS SIMPLY WITHDRAWN FROM THE PATIENT ANATOMY. A NEW 3.0X33MM MULTI-LINK 8 SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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
    808592 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 3032841

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR