BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SKYPOINT¿

    MDR report key: 23921344 · Received December 30, 2025

    Report

    Report Number
    2024168-2025-12275
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    October 16, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NIQ
    UDI-DI
    08717648233562
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. THE REPORTED PATIENT EFFECT OF CARDIAC FAILURE (HEART FAILURE/CONGESTIVE HEART FAILURE) IS LISTED IN THE XIENCE SKYPOINT, EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), ELECTRONIC INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED CARDIAC FAILURE (HEART FAILURE/CONGESTIVE HEART FAILURE) COULD NOT BE DETERMINED; HOWEVER, THE SUBSEQUENT HOSPITALIZATION OR PROLONGED HOSPITALIZATION 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.

    Description of Event or Problem · 0

    (B)(4). IT WAS REPORTED THAT ON (B)(6) 2023 ONE 4.5X18 MM XIENCE SKYPOINT LV (LOT 2030141) WAS IMPLANTED IN THE LEFT MAIN CORONARY ARTERY AND ONE 3.0X33 MM XIENCE SKYPOINT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2023, THE PATIENT, WHO HAS A HISTORY OF CONGESTIVE HEART FAILURE, WAS RE-ADMITTED TO THE HOSPITAL WITH ACUTE ON CHRONIC HEART FAILURE. AFTER THE PATIENT WAS OBSERVED, THE PATIENT WAS DISCHARGED ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2259977 XIENCE SKYPOINT¿ CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR INC. 1804450-18 2030141 08717648233562

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other| H LAD STENT: 3.0X33 MM XIENCE SKYPOINT.