BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3092873 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02787
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. PATIENT EFFECTS OF CARDIAC ARREST, DEATH, AND MYOCARDIAL INFARCTION, AS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, AN EMERGENCY PROCEDURE WAS PERFORMED, DURING WHICH LESIONS WERE NOTED IN THE 1ST DIAGONAL BRANCH AND THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX). A 2.5 X 14 MM NON-ABBOTT STENT WAS IMPLANTED IN THE 1ST DIAGONAL BRANCH. A 2.5 X 15 MM XIENCE PRIME STENT WAS IMPLANTED IN THE DISTAL LCX WITH ONE INFLATION AT 8 ATMOSPHERES (ATM) FOR 30 SECONDS AND ANOTHER INFLATION AT 14 ATM FOR 30 SECONDS. INTRA-VASCULAR ULTRA SOUND (IVUS) WAS PERFORMED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. ON (B)(6) 2013, THE PATIENT FELL OVER AT A SHOPPING CENTER AND WAS TRANSPORTED TO THE HOSPITAL UNDER CARDIAC ARREST WITH CARDIOPULMONARY RESUSCITATION (CPR) BEING PERFORMED. HOWEVER THE PATIENT WAS DEAD. THE CAUSE OF DEATH WAS REPORTED TO BE SUSPICION OF MYOCARDIAL INFARCTION (MI). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195118 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2091941

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death STENT: NOBORI 2.5 X 14 MM