BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT STYSTEM

    MDR report key: 1021528 · Received March 26, 2008

    Report

    Report Number
    2024168-2008-00216
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 26, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. FACTORS THAT CAN AFFECT STENT DISLODGEMENT OUTSIDE THE BODY INCLUDED, BUT ARE NOT LIMITED TO, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING PREP, FORCED SHEATH REMOVAL, OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURING. BASED ON THE INCIDENT INFORMATION, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED COMPLAINT OF STENT DISLODGEMENT CANNOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION TO SUGGEST THE AT MATERIALS OR WORKMANSHIP MAY HAVE CAUSED OR CONTRIBUTED TO THE ANOMALY.

    Description of Event or Problem · 1

    REPORTING RATIONALE: MALFUNCTION REPORTING STATUS: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY DEVICE ISSUE: STENT DISLODGEMENT, IT WAS REPORTED THAT THE STENT DISLODGED DURING PREPARATION. A NEW VISION WAS USED WITHOUT ANY COMPLICATIONS. THERE WAS NO PATIENT INVOLVEMENT. 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 STYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 7091231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK