BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 10208978 · Received June 29, 2020

    Report

    Report Number
    2024168-2020-05410
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    June 16, 2020
    Report Date
    June 29, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 IDENTIFIED NO OTHER INCIDENTS. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS DE NOVO LEFT CIRCUMFLEX. THE 2.75X15MM MULTI-LINK 8 STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. AFTER REMOVAL OF THE SDS IT WAS FOUND THAT THE STENT HAD DISLODGED FROM THE BALLOON BUT REMAINED ON THE DELIVERY CATHETER. THE SDS WAS REPLACED WITH A 2.5X15MM NON-ABBOTT NC BALLOON TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670600 MULTI-LINK 8 CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 8083141

    Patients

    Seq Age Sex Outcome Treatment
    1