BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2841378 · Received February 10, 2009

    Report

    Report Number
    2024168-2009-00210
    Event Type
    Malfunction
    Date Received
    February 10, 2009
    Date of Event
    January 2, 2009
    Report Date
    January 5, 2009
    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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT - PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED ONLY THE STENT IMPLANT WAS RETURNED ON THE STYLET. THERE WAS NO BLOOD OR CONTRAST. IN THE MIDDLE OF THE STENT IMPLANT THERE WERE TWO STRUTS INDENTED AND SLIGHTLY FLATTENED. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE OUTER DIAMETER MEASUREMENTS DID MEET MANUFACTURING CRITERIA. THE INNER DIAMETER OF THE PROTECTIVE SHEATH WAS MEASURED WITH A PIN GAUGE. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORT STATUS: MALFUNCTION. REPORTING RATIONALE: DISLODGED STENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: DISLODGED STENT. IT WAS REPORTED THAT THE DEVICE WOULD NOT CROSS. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THIS EVENT IS BEING FILED BASED ON THE RETURN GOODS LAB ANALYSIS OF THE DEVICE, WHICH REVEALED A DISLODGED STENT.

    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 8082141

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK