BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1150005 · Received August 27, 2008

    Report

    Report Number
    2024168-2008-00723
    Event Type
    Malfunction
    Date Received
    August 27, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 28, 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

    RESULTS AND CONCLUSION SUMMATION- PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. FACTORS THAT CAN AFFECT STENT DISLODGEMENT OUTSIDE THE BODY INCLUDE, BUT ARE NOT LIMITED TO, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING PREP, FORCED SHEATH REMOVAL, INCORRECT SHEATH SIZING, OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURING. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO INDICATION TO SUGGEST THAT MATERIALS OR WORKMANSHIP MAY HAVE CAUSED OR CONTRIBUTED TO THE ANOMALY.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS OCCURRED IN PATIENT ANATOMY AND CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT DURING A PROCEDURE, THE STENT WAS OPENED AND PREPPED. BOTH THE ACCOUNT MANAGER AND THE PHYSICIAN THOUGHT THEY OBSERVED THE STENT ON THE STENT DELIVERY SYSTEM PRIOR TO INSERTION INTO THE PATIENT. THE DEVICE WAS THEN ADVANCED INTO THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE PHYSICIAN FELT THAT THE STENT WAS PLACED AND DEPLOYED WITH NO PROBLEM. ALTHOUGH IT WAS DIFFICULT TO SEE THE STENT UNDER FLUORO, AS THE PATIENT WAS VERY HEAVY, THE RESULT WAS GOOD AND THE CASE WAS COMPLETED. BECAUSE THE PHYSICIAN DID NOT FEEL COMFORTABLE ABOUT THE VISIBILITY OF THE STENT, AND THE FACT IT MAY HAVE NEVER BEEN ON THE STENT DELIVERY SYSTEM IN THE FIRST PLACE, THE PATIENT WAS BROUGHT BACK IN FOR A CT AND NO STENT COULD BE FOUND. THE PATIENT HAD A SUCCESSFUL ANGIOPLASTY RESULT FROM THE INITIAL PROCEDURE AND WAS EXPERIENCING NO SYMPTOMS. NO PATIENT EFFECTS HAVE BEEN REPORTED. 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 8051941

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR