BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1345352 · Received January 8, 2009

    Report

    Report Number
    2024168-2009-00011
    Event Type
    Malfunction
    Date Received
    January 8, 2009
    Date of Event
    December 5, 2008
    Report Date
    December 9, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING COULD NOT PERFORM AN EVALUATION AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE. THE STENT IMPLANT WAS RETURNED IN THE PROXIMAL END OF THE PROTECTIVE SHEATH, DISLODGED FROM THE SDS. THE STENT IMPLANT WAS FLIPPED IN THE PROTECTIVE SHEATH, THE DISTAL END OF THE STENT IMPLANT WAS AT THE PROXIMAL END OF THE PROTECTIVE SHEATH. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE SDS. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE OUTER DIAMETER MEASUREMENTS MET MFG CRITERIA.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTE TO PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT WHILE REMOVING THE PROTECTIVE COVER, THE STENT CAME OFF THE BALLOON. THE STENT DELIVERY SYSTEM (SDS) WAS NOT IN CONTACT WITH THE PT. 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 7112132

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK