BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1020596 · Received March 28, 2008

    Report

    Report Number
    2024168-2008-00239
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION/HOSPITALIZATION. REPORTING RATIONALE: STENT DISLODGEMENT RESULTING IN AN ADDITIONAL PROCEDURE DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THIS WAS AN ACUTE MYOCARDIAL INFARCTION (AMI) CASE. PRE-DILATATION WAS DONE IN THE TIGHT PROXIMAL LAD. THE STENT WAS THOUGHT TO BE IMPLANTED. POST-DILATATION WAS DONE WITH ANOTHER COMPANY'S BALLOON. THE PT WAS CLOSED AND MOVED OUT OF THE CATH LAB. THE PT EXPERIENCED CHEST PAIN AND IT WAS REALIZED THAT THE STENT HAD NOT BEEN IMPLANTED; THEREFORE, ANOTHER VISION WAS IMPLANTED. THE STENT COULD NOT BE FOUND; HOWEVER, IT WAS CONFIRMED TO NOT BE IN PT; THEREFORE, IT APPEARS THAT THE STENT DISLODGED PRIOR TO USE. A PRODUCT WITH THIS ISSUE SHOULD BE IDENTIFIED DURING THE INSPECTION PRIOR TO USE, AS INDICATED IN THE PRODUCT IFU, AND SHOULD NOT BE USED ON THE PT IN THIS CONDITION. THE PT WAS RECATHETERIZED AND ANOTHER VISION WAS IMPLANTED WITH NO PT ISSUE. PT REMAINED IN THE CRITICAL CARE UNIT. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8010832

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R STENT: VISION| DILATATION CATHETER: QUANTUM