BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1050318 · Received May 22, 2008

    Report

    Report Number
    2024168-2008-00417
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 25, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: STENT DISLODGEMENT REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT AFTER STENTING, THE ENTIRE LENGTH OF THE RIGHT CORONARY ARTERY (RCA), THE GUIDE WIRE WAS REMOVED. THEN, A DISTAL LESION WAS OBSERVED, THE GUIDE WIRE WAS RE-ADVANCED AND AN ATTEMPT WAS MADE TO ADVANCE THE MINI VISION STENT DELIVERY SYSTEM (SDS) THROUGH THE STENTED RCA. HOWEVER, DURING THE ADVANCEMENT OF THE MINI VISION SDS, THE STENT IMPLANT GOT HUNG UP ON ONE OF THE PREVIOUSLY IMPLANTED STENTS AND THE MINI VISION STENT IMPLANT DISLODGED. A MICRO SNARE DEVICE WAS USED TO SUCCESSFULLY REMOVE THE DISLODGED STENT FROM THE PT'S ANATOMY. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention