BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V

    MDR report key: 22886495 · Received August 25, 2025

    Report

    Report Number
    2024168-2025-08994
    Event Type
    Death
    Date Received
    August 25, 2025
    Date of Event
    February 1, 2021
    Report Date
    August 25, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND/OR LOT NUMBER WERE NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE SKYPOINT, EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), ELECTRONIC INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF DEATH, AND THE RELATIONSHIP TO PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT UNEXPECTED MEDICAL INTERVENTION APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE INFORMATION RECEIVED IN THE COMPLAINT WAS OBTAINED THROUGH A PROACTIVE LITERATURE SEARCH. SPECIFIC MODEL AND LOT NUMBERS WERE NOT AVAILABLE AND CAUSALITY BETWEEN THE DOCUMENTED DEVICE USAGE AND THE PATIENT EFFECTS COULD NOT BE ESTABLISHED. FACTORS THAT MAY CONTRIBUTE TO THE DEATH LISTED IN THE ARTICLE INCLUDE, BUT ARE NOT LIMITED TO, DEVICE TO PATIENT INTERACTION, PATIENT ANATOMICAL CONDITIONS, DEVICE TO USER INTERACTION AND MANUFACTURING OR MATERIAL ISSUES. DUE TO THE LIMITED INFORMATION AVAILABLE, THE EXACT CAUSE CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. LITERATURE ATTACHMENT: ARTICLE TITLE: ¿AN ASPIRIN-FREE STRATEGY FOR IMMEDIATE TREATMENT FOLLOWING COMPLEX PERCUTANEOUS CORONARY INTERVENTION¿. B2, B3, B6: DATE ESTIMATED. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. D6: DATE OF IMPLANT ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARTICLE AIMED TO EVALUATE THE EFFICACY AND SAFETY OF AN ASPIRIN-FREE STRATEGY IN PATIENTS UNDERGOING COMPLEX PERCUTANEOUS CORONARY INTERVENTION (PCI). A PRESPECIFIED SUBGROUP ANALYSIS WAS CONDUCTED BASED ON COMPLEX PCI IN THE STOPDAPT-3 (SHORT AND OPTIMAL DURATION OF DUAL ANTIPLATELET THERAPY AFTER EVEROLIMUS-ELUTING COBALT-CHROMIUM STENT-3), WHICH RANDOMLY COMPARED LOW-DOSE PRASUGREL (3.75 MG/D) MONOTHERAPY TO DUAL ANTIPLATELET THERAPY (DAPT) WITH LOW-DOSE PRASUGREL AND ASPIRIN IN PATIENTS WITH ACUTE CORONARY SYNDROME OR HIGH BLEEDING RISK. THE COPRIMARY ENDPOINTS WERE MAJOR BLEEDING EVENTS (BLEEDING ACADEMIC RESEARCH CONSORTIUM 3 OR 5) AND CARDIOVASCULAR EVENTS (A COMPOSITE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, DEFINITE STENT THROMBOSIS, OR ISCHEMIC STROKE) AT 1 MONTH. ALSO UNPLANNED CORONARY, TARGET LESION AND NONTARGET LESION REVASCULARIZATION OCCURRED. DETAILS ARE LISTED IN THE ARTICLE TITLED, "AN ASPIRIN-FREE STRATEGY FOR IMMEDIATE TREATMENT FOLLOWING COMPLEX PERCUTANEOUS CORONARY INTERVENTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341871 XIENCE V CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR INC. UNK RX XIENCE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death