BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1082065 · Received July 23, 2008

    Report

    Report Number
    2024168-2008-00599
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 22, 2008
    Report Date
    June 23, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION: PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. FACTORS THAT CAN AFFECT STENT DISLODGEMENT OUTSIDE THE BODY INCLUDE, BUT ARE NOT LIMITED TO, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE. REPORTEDLY, THERE WAS NO PT INVOLVEMENT IN THIS CASE. UNFORTUNATELY, WITHOUT THE DEVICE TO EXAMINE, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED DISCREPANCY COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT WAS OBSERVED TO BE DISLODGED WHEN UNPACKED. THERE WAS NO PT INVOLVEMENT. NO ADDITIONAL 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 8012131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK