BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

    MDR report key: 17557948 · Received August 16, 2023

    Report

    Report Number
    2024168-2023-08895
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    July 24, 2023
    Report Date
    October 3, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648233432
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED COMPLAINT WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE AS THE RESPECTIVE LOTS WERE MANUFACTURED APPROXIMATELY FIVE MONTHS APART ON DIFFERENT PRODUCTION LINES AND A QUERY OF THE SAP SYSTEM INDICATED THE ACCOUNT RECEIVED BOTH PART/LOT NUMBERS. ALL CURRENTLY AVAILABLE EVIDENCE POINTS TO THE PLACEMENT OF THE XIENCE SKYPOINT 3.5 X 38 IN THE CHIPBOARD BOX FOR A 1804350-33 AND LOT NUMBER 2061341 HAVING OCCURRED AT THE ACCOUNT; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN OPENING THE CHIPBOARD BOX OF THE 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) THE INSIDE POUCH WAS LABELED AS 3.5X38MM XIENCE SKYPOINT SDS (LOT# 2111541). THEREFORE, THE SDS WAS NOT USED IN A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER XIENCE SKYPOINT STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762007 XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 2061341 08717648233432

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown