BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE SKYPOINT¿

    MDR report key: 20201401 · Received September 12, 2024

    Report

    Report Number
    2024168-2024-10724
    Event Type
    Death
    Date Received
    September 12, 2024
    Date of Event
    January 6, 2025
    Report Date
    October 3, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE SKYPOINT EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF DEATH AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT TREATMENTS OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION AND UNEXPECTED MEDICAL INTERVENTION APPEAR 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. B2 - DATE OF DEATH: ESTIMATED. B3 - DATE OF EVENT: ESTIMATED. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. D6A - IMPLANT DATE: ESTIMATED. THE ADDITIONAL PATIENT EFFECTS REPORTED IN THE ARTICLE ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. LITERATURE: ARTICLE TITLE ¿POST-MARKET CLINICAL FOLLOW-UP EVALUATION REPORT XIENCE FAMILY OF STENTS¿.

    Additional Manufacturer Narrative · 0

    CORRECTIONS: A2 ¿ AGE AT TIME OF EVENT: UPDATED FROM 68 TO 69. B2 ¿ DATE OF DEATH: UPDATED FROM (B)(6) 2025. B3 - DATE OF EVENT UPDATED FROM (B)(6) 2025. B7 - OTHER RELEVANT HISTORY: UPDATED. C4: TREATMENT/THERAPY START DATE ESTIMATED AS (B)(6) 2025. D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED. D6A - IMPLANT DATE UPDATED FROM (B)(6) 2025. H6 - TYPE OF INVESTIGATION: CODE 4109 WAS REMOVED. THE ADDITIONAL PATIENT EFFECTS REPORTED IN THE ARTICLE ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT PATIENT DEATH. IT WAS REPORTED THROUGH THE POST-MARKET CLINICAL FOLLOW-UP (PMCF) EVALUATION REPORT XIENCE FAMILY OF STENTS, THAT THERE WAS A SMALL PERCENTAGE OF XIENCE SKYPOINT PATIENTS WHO EXPERIENCED DEATH (ALL CAUSE MORTALITY [ACM]), MYOCARDIAL INFARCTION (MI), RESTENOSIS, TARGET VESSEL/LESION REVASCULARIZATION AFTER THE PROCEDURE. THE OVERALL ANALYSIS DEMONSTRATES THAT THE SAFETY AND PERFORMANCE OUTCOMES WITH XIENCE FAMILY OF STENTS ARE COMPARABLE TO THOSE WITH OTHER COMMON DES. SKYPOINT PROCEDURES TOOK PLACE FROM THE YEAR 2022 TO 2023. PLEASE SEE THE POST MARKET CLINICAL FOLLOW UP (PMCF) EVALUATION REPORT FOR SPECIFIC INFORMATION.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORTS, ADDITIONAL INFORMATION WAS RECEIVED ON 9/08/2025 WHEN MORE DATA WAS COLLECTED FOR THE POST-MARKET CLINICAL FOLLOW-UP EVALUATION REPORT XIENCE FAMILY OF STENTS. XIENCE SKYPOINT PATIENTS EXPERIENCED DEATH, MYOCARDIAL INFARCTION, RESTENOSIS, OCCLUSION, THROMBUS, TARGET VESSEL/LESION REVASCULARIZATION AND HOSPITALIZATION. SKYPOINT PROCEDURES TOOK PLACE FROM (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505984 XIENCE SKYPOINT¿ CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR INC. UNK XIENCE SKYPOINT

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death