BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1211509 · Received October 22, 2008

    Report

    Report Number
    2024168-2008-01000
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 26, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION- PHYSICAL RESISTANCE CAN BE AFFECTED BY NUMEROUS FACTORS; HOWEVER, CONSIDERING THE ADDITIONAL PRE-DILATATION WAS NECESSARY TO CROSS THE LESION, THE ANATOMY MAY HAVE BEEN CHALLENGING. STENT DISLODGEMENT INSIDE THE BODY CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NO LIMITED TO, EXTREME TORTUOSITY OR LESION RESISTANCE, INTERACTION OF THE STENT WITH ACCESSORY DEVICE, EXCESSIVE FORCE NEEDED TO RETRACT UNEMPLOYED STENT INTO GUIDING CATHETER, OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE. IT IS POSSIBLE THAT WHILE ATTEMPTING TO CROSS THE LESION, THE STENT BECAME DISRUPTED ON THE BALLOON FACILITATING THE DISLODGEMENT. THE ULTIMATE ROOT CAUSE OF THE STENT DISLODGEMENT IS UNKNOWN.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/PERMANENT DAMAGE. REPORTING RATIONALE: DISLODGED STENT FREE FLOATING IN THE ANATOMY IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE MINI VISION STENT DELIVERY SYSTEM (SDS) DID NOT CROSS THE LESION; THEREFORE, IT WAS REMOVED AND ADDITIONAL PREDILATION WAS PERFORMED. THE MINI VISION SDS WAS RE-ADVANCED AND UPON DEPLOYMENT, IT WAS NOTED UNDER FLUOROSCOPY THAT THERE WAS NO STENT PRESENT ON THE SDS BALLOON. THE DISLODGED STENT COULD NOT THE FOUND (IN THE PATIENT'S ANATOMY, IN ACCESSORY DEVICES AND ON/AROUND THE BACKTABLE AND CATH LAB). IT IS LIKELY THAT THE STENT DISLODGED INSIDE THE PATIENT AND REMAINS IN THE PATIENT'S ANATOMY; HOWEVER, THIS COULD NOT BE CONFIRMED. NO ADDITIONAL EVENT OR PATIENT 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 8051231

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Disability