BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3873158 · Received June 13, 2014

    Report

    Report Number
    2024168-2014-03837
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 20, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST. IT WAS CONCLUDED THAT THE IMAGES ARE CONSISTENT WITH THE INCIDENT DESCRIPTION. DEATH AND PERFORATION ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) AS KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. THE LOT HISTORY RECORD WAS REVIEWED FOR THE REPORTED LOT AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID CIRCUMFLEX ARTERY WITH MILD TORTUOSITY. PRE-DILATATION WAS PERFORMED AND THE 2.75 X 18 XIENCE V STENT WAS IMPLANTED. POST-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON. SUDDENLY, A PERFORATION OCCURRED. THE PHYSICIAN COULD NOT CONFIRM WHAT CAUSED THE PERFORATION. THE 2.8 X 26 MM GRAFTMASTER STENT WAS THEN DEPLOYED FOR TREATMENT, BUT BY THE TIME THE GRAFTMASTER HAD BEEN PLACED, THE PATIENT HAD GONE INTO ARREST, AND DIED. IT WAS CONFIRMED THAT THE PERFORATION WAS THE CAUSE OF THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350860 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3013141

    Patients

    Seq Age Sex Outcome Treatment
    1 Death