BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1220751 · Received October 31, 2008

    Report

    Report Number
    2024168-2008-01054
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT STENT MOVEMENT/LOOSE STENT CAN BE AFFECTED BY, BUT NOT LIMITED TO, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, INCORRECT SHEATH SIZING, OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE. THERE ARE IN-PROCESS CONTROLS IN PLACE, FOR STENT MOVEMENT/PLACEMENT AND CRIMPED STENT OUTER DIAMETERS TO ENSURE THAT THE STENTS ARE CRIMPED ADEQUATELY DURING MFG. ALL QUALITY PARAMETERS INCLUDING STENT PLACEMENT AND STENT MOVEMENT MET MFG CRITERIA. A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE REPORTED COMPLAINT OF LOOSE STENT, BUT THERE IS NO INDICATION OF A QUALITY ISSUE.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: LOOSE STENT HAS OCCURRED IN PT ANATOMY AND CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: LOOSE STENT. IT WAS REPORTED THAT DURING THE PREPARATION, WHEN THE PHYSICIAN REMOVED THE PROTECTIVE SHEATH, THE STENT HAD BEEN MOVED A LITTLE. THE WHOLE STENT WAS STILL ON THE BALLOON, SO IT WAS DISLODGED. 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 8042831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK