BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1341646 · Received March 9, 2009

    Report

    Report Number
    2024168-2009-00390
    Event Type
    Injury
    Date Received
    March 9, 2009
    Date of Event
    November 26, 2008
    Report Date
    February 12, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - DISSECTION IS A KNOWN POSSIBLE OUTCOME OF CORONARY STENTING PROCEDURES, AND LISTED IN THE IFU, AS A POTENTIAL ADVERSE EVENT. HOWEVER, IT WAS NOTED THAT NO PRE-DILATATION WAS PERFORMED PRIOR TO STENTING THE LESION. THE IFU STATES: "THE VESSEL SHOULD BE PRE-DILATED WITH AN APPROPRIATE SIZED BALLOON. FAILURE TO DO SO MAY INCREASE THE DIFFICULTY OF STENT PLACEMENT AND CAUSE PROCEDURAL COMPLICATIONS." ALTHOUGH A CAUSE FOR THE DISSECTION AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE ARE NO INDICATIONS OF A DEVICE DEFICIENCY WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION, REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRAIL THAT DURING THE PROCEDURE IN 2008, A 3.0 X 23 MM XIENCE V STENT WAS DEPLOYED IN THE MID LAD, WITHOUT PRE-DILATATION. AFTER THE STENT WAS DEPLOYED, A DISSECTION WAS NOTED AND AN ADDITIONAL 3.0 X 08 MM XIENCE V STENT WAS DEPLOYED TO COVER THE DISSECTION. 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 8072461

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention