BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1021527 · Received March 26, 2008

    Report

    Report Number
    2024168-2008-00217
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 29, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT DURING PREPARATION INCLUDED, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL, MISHANDLING, OR INTERACTIONS WITH OTHER DEVICES. HOWEVER, WITHOUT A RETURNED DEVICE FOR ANALYSIS, A DEFINITE ROOT CAUSE OF THE STENT DISLODGEMENT CANNOT BE DETERMINED.

    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 DURING PREPARATION, THE STENT DISLODGED ONTO THE TABLE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL PATIENT OR EVENT DETAILS ARE 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 7111931

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK