BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

    MDR report key: 16569563 · Received March 18, 2023

    Report

    Report Number
    2024168-2023-02814
    Event Type
    Death
    Date Received
    March 18, 2023
    Date of Event
    January 30, 2023
    Report Date
    May 2, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648233333
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. 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. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND DEATH ARE LISTED IN THE XIENCE SKYPOINT EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. 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.B5 - DESCRIBE EVENT OR PROBLEM: UPDATED D4 - CATALOG #. LOT #, UDI WERE UPDATED FROM "UNK XIENCE SKYPOINT/ UNKNOWN/ NI" TO: 1804325-23 / 2021141 / (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.5 TREK BALLOON DILATATION CATHETER (BDC) AND A NON-ABBOTT INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WERE USED TO PREPARE THE VESSEL, AFTER WHICH A 3.5X23MM SKYPOINT DRUG ELUTING STENT (DES) WAS IMPLANTED. VIA IMAGING, THE DISTAL END LOOKED HAZY. THROMBOSIS WAS NOTED. A 3.0 NC TREK BDC WAS USED. CARIOPULMONARY RESUSCITATION WAS STARTED BUT WAS UNSUCCESSFUL AND THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, IT WAS REPORTED THAT THE LESION WAS 90% STENOSED PRIOR TO THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998515 XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1804325-23 2021141 08717648233333

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death 2.5 TREK BDC| 3.0 NC TREK BDC| NON-ABBOTT INTRAVASCULAR LITHOTRIPSY (IVL) CATHETE