BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1203134 · Received October 8, 2008

    Report

    Report Number
    2024168-2008-00916
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 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 - QUALITY ENGINEERING REVIEWED THE INCIDENT. STENT MOVEMENT/LOOSE STENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, INADEQUATE CRIMPING DURING MANUFACTURING, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL. WITHOUT THE SDS TO EXAMINE, A CONCLUSIVE ROOT CAUSE FOR THE STENT MOVEMENT COULD NOT BE DETERMINED. THE IFU STATES, "SPECIAL CARE MUST BE TAKEN NOT TO HANDLE OR IN ANY WAY DISRUPT THE STENT ON THE BALLOON" AND "DO NOT MANIPULATE (E.G., "ROLL") THE STENT WITH YOUR FINGERS, AS THE ACTION MAY LOOSEN THE STENT FROM THE DELIVERY BALLOON."

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: A LOOSE STENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: LOOSE STENT. IT WAS REPORTED THAT DURING PREPARATION, WHEN THE PROTECTIVE SHEATH WAS REMOVED FROM THE STENT DELIVERY SYSTEM (SDS), THE STENT MOVED TO THE DISTAL SIDE. THE PHYSICIAN TIRED TO MOVE THE STENT BACK TO THE ORIGINAL POSITION, BUT THE STENT WAS UNABLE TO MOVE AT ALL. ANOTHER COMPANY'S STENT WAS USED AND THE PROCEDURE WAS COMPLETED. 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 8040431

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK