BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SKYPOINT¿

    MDR report key: 22883719 · Received August 25, 2025

    Report

    Report Number
    2024168-2025-08942
    Event Type
    Injury
    Date Received
    August 25, 2025
    Date of Event
    August 1, 2025
    Report Date
    September 3, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NIQ
    UDI-DI
    08717648230752
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3: DATE OF EVENT/PROCEDURE ESTIMATED AS (B)(6) 2025. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. D6A: ESTIMATED DATE OF IMPLANT AS (B)(6) 2025.

    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 ANGINA, THROMBOSIS AND MYOCARDIAL INFARCTION ARE LISTED IN THE XIENCE SKYPOINT, EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), ELECTRONIC 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. D4: MODEL, CATALOG NUMBER UPDATED FROM UNKNOWN STENT TO 1800350-28. D4: LOT NUMBER UPDATED FROM UNKNOWN TO 5013041.

    Description of Event or Problem · 0

    IT WAS REPORTED THROMBOSIS WAS NOTED WITHIN THE ABBOTT STENT.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORTS, ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED THE PROCEDURE WAS TO TREAT A 99% OCCLUDED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.50X28MM XIENCE SKYPOINT STENT WAS IMPLANTED WITHOUT ISSUE. POST PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN AND ECG ST ELEVATION. THE PATIENT WAS BROUGHT BACK AND BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2823917 XIENCE SKYPOINT¿ CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR INC. 1800350-28 5013041 08717648230752

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| O