BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    MDR report key: 1031708 · Received April 18, 2008

    Report

    Report Number
    2024168-2008-00323
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 21, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. POTENTIAL CAUSES OF STENT DISLODGEMENT MAY BE, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MFR, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL, INTERACTION WITH OTHER DEVICES AND/OR ANATOMY, AND LESION MORPHOLOGY. UNFORTUNATELY, WITHOUT THE DEVICE TO EXAMINE, IT IS DIFFICULT TO DETERMINE A CONCLUSIVE ROOT CAUSE, HOWEVER, THE MFG RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMING MATERIAL REPORTS ISSUED FOR THIS LOT.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE 2.75 X 13 MM ZETA STENT DISLODGED PRIOR TO USE. A MINIVISION WAS USED, BUT WAS UNABLE TO CROSS THE LESION. NO PT EFFECTS WERE REPORTED. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX ZETA CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 7052431

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK