BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SKYPOINT¿

    MDR report key: 23100934 · Received September 19, 2025

    Report

    Report Number
    2024168-2025-10084
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    August 26, 2025
    Report Date
    October 17, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NIQ
    UDI-DI
    08717648230639
    PMA / PMN Number
    P110019
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. D4- A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT KNOWN.

    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. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED STENT RECOIL COULD NOT BE DETERMINED. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENT APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE REPORTED PATIENT EFFECT OF ANGINA IS LISTED IN THE XIENCE SKYPOINT EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED. D4: CORRECTED LOT NUMBER FROM UNKNOWN TO 5040341. D4: CORRECTED PRIMARY UDI NUMBER FROM (B)(4) TO (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DIAGONAL CORONARY ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. ON (B)(6) 2025 THE 3.0X15 MM XIENCE SKYPOINT STENT WAS IMPLANTED AND THERE WAS ELASTIC RECOIL AS THE VESSEL WAS NOT PREPPED. THE PATIENT EXPERIENCED CHEST PAIN. THE NEXT DAY, POST-DILATATION WAS PERFORMED, AS WELL AS IMAGING WITH OPTICAL COHERENCE TOMOGRAPHY (OCT) AND MORE POST-DILATATION WAS PERFORMED, RESULTING IN TIMI III FLOW AND THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1721566 XIENCE SKYPOINT¿ CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR INC. 1800300-15 5040341 08717648230639

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H