BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 22865046 · Received August 21, 2025

    Report

    Report Number
    2024168-2025-08844
    Event Type
    Death
    Date Received
    August 21, 2025
    Date of Event
    February 1, 2021
    Report Date
    August 21, 2025
    Manufacturer
    ABBOTT VASCULAR
    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 DEVICES WERE 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 NUMBERS AND LOT NUMBERS WERE NOT REPORTED. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF DEATH 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. FACTORS THAT MAY CONTRIBUTE TO THE PERFORMANCE OUTCOMES 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. THE REPORTED PATIENT EFFECT OF IS DEATH ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. B2, B3, B6, D6: DATES ESTIMATED D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. THE ADDITIONAL PATIENT EFFECTS AND/OR MALFUNCTIONS REPORTED IN THE ARTICLE ARE CAPTURED UNDER A SEPARATE MEDWATCH REPORT. ATTACHMENT: ARTICLE TITLED "ASPIRIN-FREE STRATEGY FOR PERCUTANEOUS CORONARY INTERVENTION IN ACUTE CORONARY SYNDROME BASED ON THE SUBTYPES OF ACUTE CORONARY SYNDROME AND HIGH BLEEDING RISK: THE STOPDAPT-3 TRIAL".

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT 4476 ACUTE CORONARY SYNDROME (ACS) PATIENT'S ENROLLED IN THE STOP DAPT-3, WHERE THE NO-ASPIRIN AND DUAL ANTIPLATELET THERAPY (DAPT) STRATEGIES AFTER PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH XIENCE STENTS WERE RANDOMLY COMPARED. THE ANALYSIS WAS BROKEN DOWN INTO FOUR SUBGROUPS HIGH BLEEDING RISK (HBR), NON-HBR AND ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION AND NON-ST-SEGMENT ELEVATION ACS (NSTE-ACS). THE CO-PRIMARY BLEEDING ENDPOINT WAS BLEEDING ACADEMIC RESEARCH CONSORTIUM( BARC) TYPE 3 OR 5, AND THE CO-PRIMARY CARDIOVASCULAR ENDPOINT WAS A COMPOSITE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, DEFINITE STENT THROMBOSIS, ACUTE THROMBOSIS, SUBACUTE THROMBOSIS, OR ISCHAEMIC STROKE AT 1 MONTH, WHICH ALL GROUPS SUFFERED. IT WAS ALSO NOTED TARGET LESION REVASCULARIZATION. IN PATIENTS WITH ACS UNDERGOING PCI, THE NO-ASPIRIN STRATEGY COMPARED WITH THE DAPT STRATEGY FAILED TO REDUCE MAJOR BLEEDING EVENTS IRRESPECTIVE OF HBR AND ACS SUBTYPES. THE NUMERICAL EXCESS RISK OF THE NO-ASPIRIN STRATEGY RELATIVE TO THE DAPT STRATEGY FOR CARDIOVASCULAR EVENTS WAS OBSERVED IN PATIENTS WITH HBR AND IN PATIENTS WITH NSTE-ACS. SPECIFIC PATIENT INFORMATION REMAINS UNKNOWN. ADDITIONAL INFORMATION CAN BE FOUND IN THE ARTICLE "ASPIRIN-FREE STRATEGY FOR PERCUTANEOUS CORONARY INTERVENTION IN ACUTE CORONARY SYNDROME BASED ON THE SUBTYPES OF ACUTE CORONARY SYNDROME AND HIGH BLEEDING RISK: THE STOPDAPT-3 TRIAL". NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409722 XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death