BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 9986496 · Received April 22, 2020

    Report

    Report Number
    2024168-2020-03826
    Event Type
    Malfunction
    Date Received
    April 22, 2020
    Date of Event
    April 8, 2020
    Report Date
    June 1, 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 · 0

    A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED MATERIAL SEPARATION WAS CONFIRMED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE TESTED AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL RX MULTI-LINK DEVICE IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS DE NOVO MID LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS DONE WITH A 2.5X25MM TREK. A 2.5X18MM MULTI-LINK 8 STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE ANATOMY AND DURING WITHDRAWAL THE MID SHAFT SEPARATED. THE DEVICE WAS SIMPLY WITHDRAWN. THE DEVICE WAS REPLACED WITH A NON-ABBOTT 2.5X19MM STENT. A 2.5X28MM MULTI-LINK 8 STENT DELIVERY SYSTEM WAS REMOVED FROM THE DISPENSER COIL WITH SLIGHT RESISTANCE. THERE WAS SLIGHT RESISTANCE REMOVING THE PROTECTIVE SHEATH AND FORCE WAS USED. THE STENT BECAME DISLODGED AND FOUND IN THE PROTECTIVE SHEATH. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS REPLACED WITH A NON-ABBOTT 2.5X27MM STENT. 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
    449887 MULTI-LINK 8 CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 9051041

    Patients

    Seq Age Sex Outcome Treatment
    1