BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1031705 · Received April 18, 2008

    Report

    Report Number
    2024168-2008-00327
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 21, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PERFORMANCE GROUP WAS NOT ABLE TO PERFORM AN EVALUATION 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 RETURNED WITHOUT BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE ON THE BALLOON, ON THE DISTAL SHAFT, IN THE INFLATION LUMEN AND IN THE NOSEPIECE. THE STENT IMPLANT WAS NOT RETURNED. THE PROTECTIVE SHEATH WAS NOT RETURNED. THE BALLOON WAS LOOSELY FOLDED. THERE WERE CRIMP MARKS ON THE BALLOON AND BETWEEN THE MARKERS. THERE WERE TWO BENDS IN THE HYPOTUBE, 34 CM AND 62 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. PRODUCT PERFORMANCE GROUP WAS NOT ABLE TO PERFORM AN EVALUATION 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: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LAD WHICH HAD BEEN PRE-DILATED. DURING DEPLOYMENT OF THE STENT, THE BALLOON MOVED. UNDER FLUORO THE STENT COULD NOT BE SEEN. THEY USED HIGH DENSITY FLUORO AND COULD NOT LOCATE THE STENT ANYWHERE IN THE CORONARY. THE GUIDING CATHETER WAS ALSO CHECKED AND THE STENT WAS NOT THERE. A CUTTING BALLOON WAS THEN USED IN THE LESION AND A 3.5 X 18 MM VISION STENT WAS SUCCESSFULLY DEPLOYED. IT WAS INSISTED THAT THE STENT DISLODGED DURING UNPACKING. THERE WERE NO PATIENT EFFECTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 8012131

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR OTHER: CUTTING BALLOON| STENT: 3.5 X 18 MM VISION