BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 22974644 · Received September 4, 2025

    Report

    Report Number
    2024168-2025-09483
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    January 1, 2020
    Report Date
    September 4, 2025
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. THE REPORTED PATIENT EFFECT(S) OF THROMBOSIS, STROKE, AND MYOCARDIAL INFARCTION ARE LISTED IN THE XIENCE PRIME, XIENCE PRIME SMALL VESSEL (SV), AND XIENCE PRIME LONG LENGTH (LL), EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), 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. 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. B3, D6A: DATE ESTIMATED. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. THE ADDITIONAL PATIENT EFFECT OF DEATH REPORTED IN B5 IS CAPTURED UNDER SEPARATE MEDWATCH REPORT. ARTICLE TITLED; " ULTRASONIC FLOW RATIO MEASURED IMMEDIATELY AFTER SUCCESSFUL ROTATIONAL ATHERECTOMY WITH STENT IMPLANTATION PREDICTS MAJOR ADVERSE CARDIOVASCULAR EVENTS."

    Description of Event or Problem · 0

    IT WAS REPORTED IN A SUMMARY ARTICLE THAT A TOTAL OF 68 PATIENTS WITH HIGHLY CALCIFIC LESIONS, WHO UNDERWENT BOTH QUANTITATIVE FLOW RATIO (QFR) AND ULTRASONIC FLOW RATIO (UFR) MEASUREMENTS AFTER PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH BOTH (ROTATIONAL ATHERECTOMY) RA AND STENTING, WERE ANALYZED FOR THE ABILITY TO PREDICT MAJOR ADVERSE CORONARY EVENTS (MACE) AT 12-MONTH FOLLOW-UP. AN XIENCE PRIME STENTS AND NON-ABBOTT STENTS WERE IMPLANTED. MACE EVENTS REPORTED WERE ALL-CAUSE MORTALITY, MYOCARDIAL INFARCTION, ISCHEMIC STROKE, TRANSIENT ISCHEMIC ATTACK, STENT THROMBOSIS, AND TARGET VESSEL REVASCULARIZATION. THE ARTICLE FOUND THAT LOWER VALUE OF POST-PCI UFR IS AN INDEPENDENT PREDICTOR OF 12-MONTH MACE AFTER PCI WITH RA AND STENT IMPLANTATION IN PATIENTS WITH HIGHLY CALCIFIED LESIONS. ADDITIONAL INFORMATION CAN BE FOUND IN THE SUMMARY ARTICLE, "ULTRASONIC FLOW RATIO MEASURED IMMEDIATELY AFTER SUCCESSFUL ROTATIONAL ATHERECTOMY WITH STENT IMPLANTATION PREDICTS MAJOR ADVERSE CARDIOVASCULAR EVENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264385 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 70 YR Unknown Disability| H| R| L