BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1013274 · Received March 14, 2008

    Report

    Report Number
    2024168-2008-00184
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE AN INVESTIGATION AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON INVESTIGATION COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM(SDS) WAS RETURNED WITHOUT BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN. THE STENT IMPLANT WAS RETURNED DISLODGED ON THE STYLE IN 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 WERE THREE KINKS IN THE INFLATION LUMEN 11 CM, 11.8 CM, AND 13.1 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. A LASER MICROMETER WAS USED TO MEASURE THE STENT IMPLANT OUTER DIAMETERS AND THEY DID NOT MEET MFG CRITERIA. THE PROXIMAL AND MIDDLE MEASUREMENTS WERE OVERSIZED. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE AN INVESTIGATION AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS OCCURRED IN PT ANATOMY AND CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT WHILE GETTING READY TO INSERT THE DEVICE INTO A SAPHENOUS VEIN GRAFT, THE STENT WAS NOT SEEN ON ANGIOGRAPHY. THE DEVICE WAS REMOVED FROM THE PT. THE DISLODGED STENT WAS FOUND ON THE MANDREL, OUTSIDE OF THE PT. ANOTHER VISION WAS USED WITH NO ISSUES. NO PT INJURY WAS REPORTED. NO ADD'L 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 7022031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT: VISION