BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1132125 · Received August 21, 2008

    Report

    Report Number
    2024168-2008-00691
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO: IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MFR, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION, AND INTERACTION WITH THE LESION, ACCESSORY DEVICES, AND/OR PREVIOUSLY IMPLANTED STENTS. CAUSES OF DIFFICULTY TO POSITION A STENT IN THE LESION MAY INCLUDE, BUT NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, ANATOMICAL CONDITIONS, GUIDING CATHETER SUPPORT, INNER DIAMETER OF THE GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BLOOD OR CONTRAST DRYING ON THE GUIDE WIRE, OR DAMAGE TO THE DISTAL SHAFT OF THE SDS.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - PERMANENT DAMAGE. REPORTING RATIONALE: STENT POSSIBLY REMAINS IN PT ANATOMY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE XIENCE V STENT 2.75 X 15 WAS IMPLANTED IN THE PT NORMALLY; HOWEVER, AFTER THE PROCEDURE, THE STENT IMPLANT COULD NOT BE SEEN AND THE ARTERY REMAINED "CLOSED". BEFORE INTRODUCING THE STENT DELIVERY SYSTEM (SDS) INTO THE PT, THE PHYSICIAN SAW THE STENT ON THE SDS, BUT AFTER IT "DISAPPEARED". THE PHYSICIAN SCANNED THE PT LOOKING FOR THE STENT, BUT DID NOT FIND IT. THEN, A XIENCE V STENT 3 X 15 WITH INTRODUCED SUCCESS. AN UNKNOWN ANTICOAGULANT WAS PRESCRIBED TO THE PT TO BE TAKEN FOR A YEAR, DUE TO THE STENT IMPLANT. THE PT'S HOSPITALIZATION WAS NOT PROLONGED, HE WAS OBSERVED AND WAS DISCHARGED THE NEXT MORNING. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 707306Q

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability STENT: XIENCE V STENT 3.0 X 15