BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION

    MDR report key: 24487773 · Received March 2, 2026

    Report

    Report Number
    2024168-2026-00842
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    April 10, 2022
    Report Date
    March 2, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    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

    ATTACHMENT ARTICLE, TITLED " SIROLIMUS-ELUTING IRON BIORESORBABLE SCAFFOLDS VS EVEROLIMUS-ELUTING STENTS FOR PERCUTANEOUS CORONARY INTERVENTION: A RANDOMIZED TRIAL (IRONMAN II).¿ B3- DATE OF EVENT ESTIMATED AS 4/10/2022. D6A-IMPLANT DATE ESTIMATED AS (B)(6) 2022. 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 OF MYOCARDIAL INFARCTION, STENOSIS AND THROMBOSIS ARE LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, 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. THE DEATH MENTIONED IN B5 WILL BE FILED UNDER A SEPARATE REPORT.

    Description of Event or Problem · 0

    THE ARTICLE AIMED TO COMPARE THE THIN-STRUT SIROLIMUS-ELUTING IRON BIORESORBABLE SCAFFOLD (IBS) WITH THE XIENCE XPEDITION METALLIC COBALT CHROMIUM EVEROLIMUS-ELUTING STENTS (COCR-EES) IN PATIENTS WITH CORONARY ARTERY DISEASE FROM THE IRONMAN-II TRIAL. ADVERSE EVENTS ASSOCIATED WITH THE XIENCE XPEDITION STENTS INCLUDE CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, TARGET LESION REVASCULARIZATION, TARGET VESSEL REVASCULARIZATION, VESSEL RECOIL, RESTENOSIS, AND STENT THROMBOSIS. BAIL OUT STENTING WAS REQUIRED IN 3 LESIONS. THE ARTICLE CONCLUDED THE SIROLIMUS-ELUTING IBS WAS NONINFERIOR TO COCR-EES FOR 2-YEAR IN-SEGMENT LLL, QFR, AND OCT-DERIVED FLOW AREA. CLINICAL EVENT RATES WERE ALSO COMPARABLE BETWEEN GROUPS ALTHOUGH NON¿ISCHEMIA-DRIVEN REVASCULARIZATION RATES WERE HIGHER AFTER IBS. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED " SIROLIMUS-ELUTING IRON BIORESORBABLE SCAFFOLDS VS EVEROLIMUS-ELUTING STENTS FOR PERCUTANEOUS CORONARY INTERVENTION: A RANDOMIZED TRIAL (IRONMAN II).¿ NO ADDITIONAL INFORMATION WAS PROVIDED. IMPLANT DATE ESTIMATED AS (B)(6) 2022. DATE OF EVENT ESTIMATED AS 4/10/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544995 XIENCE XPEDITION CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR INC. UNK RX XPEDITION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O| R