BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1730776 · Received June 18, 2010

    Report

    Report Number
    2024168-2010-01209
    Event Type
    Death
    Date Received
    June 18, 2010
    Date of Event
    May 25, 2010
    Report Date
    May 26, 2010
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). DEATH AND PERFORATION ARE KNOWN ADVERSE PATIENT EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: PERFORATION, DEATH. TIME OF ADVERSE EVENT: UNK. IT WAS REPORTED THAT DURING INFLATION OF A 3.5 XIENCE STENT TO 16 ATMOSPHERES IN AN UNSPECIFIED VESSEL, THE VESSEL PERFORATED LEADING TO THE PATIENT'S DEATH OVER AN UNSPECIFIED AMOUNT OF TIME. THE PATIENT'S DEATH DID NOT OCCUR DURING THE PROCEDURE. THE PHYSICIAN HAD ASKED FOR A 2.5 STENT, BUT WAS GIVEN A 3.5 INSTEAD. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death