BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 22807542 · Received August 14, 2025

    Report

    Report Number
    2024168-2025-08468
    Event Type
    Death
    Date Received
    August 14, 2025
    Date of Event
    January 1, 2012
    Report Date
    August 14, 2025
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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/OR LOT NUMBERS WERE NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE REPORTED PATIENT EFFECT OF DEATH ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT 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: A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT KNOWN. ATTACHMENT: ARTICLE TITLED, " SECOND-GENERATION EVEROLIMUS-ELUTING INTRACORONARY STENTS: A COMPREHENSIVE REVIEW OF THE CLINICAL EVIDENCE."

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE REGARDING PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH IMPLANTATION OF SECOND GENERATION DRUG-ELUTING STENTS (DES) HAS EMERGED AS A MAINSTAY FOR THE TREATMENT OF OBSTRUCTIVE CORONARY ARTERY DISEASE GIVEN ITS BENEFICIAL IMPACT ON CLINICAL OUTCOMES IN THESE PATIENTS. VARIOUS CLINICAL STUDIES HAVE DEMONSTRATED THE EFFICACY AND SAFETY OF XIENCE STENTS IN TREATING A BROAD RANGE OF PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS AND WOMEN, AND COMPLEX LESION MORPHOLOGIES SUCH AS LEFT MAIN DISEASE, SMALL VESSELS, LONG LESIONS AND CHRONIC TOTAL OCCLUSION. HOWEVER, CLINICAL STUDIES HAVE ALSO MENTIONED ADVERSE EFFECT OUTCOMES FOR THE FOLLOWING XIENCE STENTS; XIENCE PRIME (TARGET VESSEL FAILURE (TVF), TARGET LESION FAILURE (TLF), MYOCARDIAL INFRACTION (MI), MAJOR ADVERSE CARDIAC EVENTS (MACE), ISCHEMIA, STROKE, BLEEDING, CARDIAC DEATH, TARGE VESSEL REVASCULARIZATION (TVR)), XIENCE ALPINE (ISCHEMIA AND BLEEDING), XIENCE XPEDITION (MI, TLR, DEATH, ISCHEMIA, TVR AND BLEEDING), XIENCE PRO (ISCHEMIA AND BLEEDING), XIENCE V (MACE, STROKE, DEATH, MI, TLR, ISCHEMIA, TVR AND BLEEDING), XIENCE STENTS (DEATH, MI, STROKE, ISCHEMIA, TLR, BLEEDING, TVR), PROMUS (TLR). ANOTHER VERSION OF DES WITH BIODEGRADABLE POLYMER COATING IS EMERGING BUT THEIR ADVANTAGE OVER EVEROLIMUS-ELUTING STENTS (EES) REMAINS UNCERTAIN. SECOND-GENERATION DES, PARTICULARLY THE XIENCE FAMILY OF STENTS, HAVE EMERGED AS THE MOST UTILIZED STENTS FOR TREATMENT OF PATIENTS WITH CORONARY ARTERY DISEASE (CAD) UNDERGOING PCI. THESE STENTS ARE NOW ONE OF THE MOST WIDELY USED SECOND GENERATION DES GLOBALLY AND APPROVED BY ALL MAJOR INTERNATIONAL REGULATORY BODIES. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED "SECOND-GENERATION EVEROLIMUS-ELUTING INTRACORONARY STENTS: A COMPREHENSIVE REVIEW OF THE CLINICAL EVIDENCE". NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627090 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR UNK RX PRIME

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death