BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1052384 · Received May 23, 2008

    Report

    Report Number
    2024168-2008-00423
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE EVAL OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE IN THE BALLOON, IN THE INFLATION LUMEN, ON THE BALLOON, ON THE DISTAL SHAFT, AND ON THE HYPOTUBE. THERE WAS CONTRAST VISIBLE IN THE BALLOON AND IN THE INFLATION LUMEN. THE STENT IMPLANT WAS NOT RETURNED, BECAUSE IT REMAINS IN THE PT. THE BALLOON WAS LOOSELY FOLDED. THE SDS WAS RETURNED WITH THE OUTER MEMBER SEPARATED 7.5 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH AT THE MID CATHETER JUNCTION. THE DISTAL END OF THE HYPOTUBE WAS PULLED OUT OF THE DISTAL SHAFT. THE MID SHAFT MATERIAL AT THE SEPARATION WAS STRETCHED. THERE WAS ADHESIVE ON THE SEPARATED SHAFT WITH ONE SIDE OF THE LUMEN HAVING 1 MM OF ADHESIVE VISIBLE. THE OTHER SIDE HAD <.25MM OF ADHESIVE VISIBLE. THERE WERE TWO BENDS IN THE HYPOTUBE, 54 CM AND 74 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE EVAL OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: FAILURE TO DEFLATE/SHAFT SEPARATION IS LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: FAILURE TO DEFLATE/SHAFT SEPARATION. IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT WAS IMPLANTED SUCCESSFULLY. NEGATIVE PRESSURE WAS THEN APPLIED TO DEFLATE THE BALLOON; HOWEVER, AT THIS MOMENT, THE SHAFT SEPARATED AT THE JUNCTION. THE PROXIMAL SHAFT WAS WITHDRAWN AND THE DISTAL SHAFT WAS REMOVED OVER THE WIRE WITH THE BALLOON PARTIALLY INFLATED. OUTSIDE THE PT, THE BALLOON REMAINED PARTIALLY INFLATED. THERE WERE NO CONSEQUENCES TO THE PT. 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 8013131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK