BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    MDR report key: 1070973 · Received July 3, 2008

    Report

    Report Number
    2024168-2008-00547
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 13, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION-PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. ADD'L INFO REC'D STATED THAT THE STENT HAD BEEN POSITIONED INCORRECTLY ON THE BALLOON. HOWEVER, IT IS UNCLEAR WHETHER THE STENT WAS LOOSE OR TIGHTLY CRIMPED ONTO THE BALLOON. FACTORS THAT CONTRIBUTE TO THE STENT MOVEMENT/DISLODGEMENT OUTSIDE THE BODY INCLUDE, BUT ARE NOT LIMITED TO, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MFR, AND HANDLING OF THE STENT DURING PREP. 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: LOOSE STENT HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: LOOSE STENT. IT WAS REPORTED THAT AFTER SUCTIONING THE THROMBUS, THE 2.75 X 18 ZETA WAS PREPARED FOR USE; HOWEVER, THE STENT HAD MOVED. IT IS NOT CLEAR WHICH WAY (DISTAL OR PROXIMAL) AND HOW MUCH THE STENT HAD MOVED. A NEW DEVICE WAS SELECTED TO COMPLETE THE PROCEDURE. 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 7112131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK