BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1012705 · Received March 12, 2008

    Report

    Report Number
    2024168-2008-00177
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROD PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVAL SUMMARY: QA ANALYSIS REVEALED THAT THE STENT DELIVERY SYS (SDS) WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON, BUT NOT BETWEEN THE MARKERS. THE PROXIMAL END OF THE STENT IMPLANT WAS 1.4 CM DISTAL TO THE PROXIMAL MARKER. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS. THE BALLOON WAS TIGHTLY FOLDED. THERE WAS A KINK IN THE HYPOTUBE 79.5 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. A LASER MICROMETER WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE PROXIMAL MEASUREMENTS MET MFG CRITERIA. THE MIDDLE AND DISTAL MEASUREMENTS WERE OVERSIZED AND DID NOT MEET MFG CRITERIA. PROD 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

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: LOOSE STENT HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: LOOSE STENT. IT WAS REPORTED THAT THE STENT WAS NOTED TO BE LOOSE ON THE BALLOON OUT OF THE BOX. THE DEVICE WAS NOT USED ON THE PT. NO PT EFFECTS WERE 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 8010831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK