BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1001919 · Received February 21, 2008

    Report

    Report Number
    2024168-2008-00128
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 22, 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

    RESULTS AND CONCLUSION SUMMATION - IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE (IFU) STATES, "WHEN TREATING MULTIPLE LESIONS, STENT THE DISTAL LESION PRIOR TO STENTING THE PROXIMAL LESION. STENTING IN THIS ORDER OBVIATES THE NEED TO CROSS THE PROXIMAL STENT IN PLACEMENT OF THE DISTAL STENT AND REDUCES THE CHANCE OF DISLODGING THE PROXIMAL STENT." POTENTIAL CAUSES OF STENT DISLODGEMENT ARE, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MFR, POSITIVE PRESSURE AT PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL, INTERACTION WITH OTHER DEVICES AND/OR ANATOMY AND LESION MORPHOLOGY. THE INABILITY TO CROSS/STENT DISLODGEMENT IN THIS CASE APPEARS TO BE RELATED TO THE PREVIOUSLY IMPLANTED STENT.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/PERMANENT DAMAGE. REPORTING RATIONALE: DISLODGED STENT REMAINS IN THE PT'S ANATOMY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE 2.25 X 08 MM MINI VISION STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO A LESION DISTAL TO A PREVIOUSLY IMPLANTED STENT, BUT THE STENT COULD NOT CROSS THE PROXIMAL STENT. THEN, UPON REMOVAL OF THE SDS, THE STENT IMPLANT WAS NOTED TO HAVE DISLODGED INSIDE THE PT'S ANATOMY. THE STENT IMPLANT COULD NOT BE LOCATED DESPITE EVERY ATTEMPT TO LOCATE IT, AND IS BELIEVED TO BE SOMEWHERE IN THE PT'S ANATOMY. REPORTEDLY, THE PT IS IN STABLE CONDITION. 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 YR Disability