BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK OTW VISION CORONARY STENT SYSTEM

    MDR report key: 1003757 · Received February 22, 2008

    Report

    Report Number
    2024168-2008-00139
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 9, 2008
    Report Date
    January 25, 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
    ME, US
    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. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITHOUT BLOOD VISIBLE. THERE WAS CRYSTALLIZED CONTRAST VISIBLE IN THE INFLATION LUMEN. THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE SDS. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS VISIBLE BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. A LASER MICROMETER WAS USED TO MEASURE THE STENT IMPLANT OUTER DIAMETERS AND THEY DID NOT MEET MANUFACTURING CRITERIA. 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/NO MEDICAL INTERVENTION, HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: LOOSE/STENT DISLODGEMENT. IT WAS REPORTED THAT THE 3.5 X 11 MM VISION STENT IMPLANT WAS LOOSE AND DISLODGED OFF OF THE STENT DELIVERY SYSTEM (SDS) BALLOON DURING PREPARATION OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT WITH THIS DEVICE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK OTW VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 7042731

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK