BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1060974 · Received June 12, 2008

    Report

    Report Number
    2024168-2008-00482
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 10, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING HAS NOT COMPLETED THEIR INVESTIGATION AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVAL SUMMARY QA ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITHOUT BLOOD AND CONTRAST VISIBLE. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON. THE DISTAL END OF THE STENT IMPLANT WAS 4.5 MM PROXIMAL TO THE END OF THE TIP. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS RETURNED. A SNAP GAUGE WAS USED TO MEASURE THE STENT IMPLANT OUTER DIAMETERS AND THEY DID NOT MEET MFG CRITERIA. THE OUTER DIAMETERS WERE OVERSIZED. A SNAP GAUGE WAS USED AS A DEVIATION FROM THE NORMAL TESTING DUE TO EQUIPMENT BEING SERVICED. THE INNER DIAMETER OF THE ORANGE PROTECTIVE SHEATH WAS MEASURED. PRODUCT PERFORMANCE ENGINEERING HAS NOT COMPLETED THEIR INVESTIGATION AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED THE STENT IMPLANT WAS FOUND LOOSE IN THE BOX. REPORTEDLY, THERE WAS NO PT INVOLVEMENT WITH THIS STENT DELIVERY SYSTEM (SDS). 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 8013031

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR