BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 18641969 · Received February 5, 2024

    Report

    Report Number
    2024168-2024-01413
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    October 29, 2023
    Report Date
    February 23, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED BREAK. 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.D4 - LOT NUMBER UPDATED FROM UNKNOWN TO LOT# 2090141. D4 - CATALOG # UPDATED FROM UNKNOWN RX XPEDITION TO 1070250-15. D4 - EXPIRATION DATE - UPDATED. D4 - UDI # UPDATED FROM NI TO (B)(4). H4 - MANUFACTURE DATE - UPDATED.

    Additional Manufacturer Narrative · 0

    B3: DATE OF OCCURRENCE ESTIMATED AS 10/29/2023. D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD (ELHR) AND LOT LEVEL SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED BECAUSE THE PART AND LOT NUMBERS WERE NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED BREAK. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) CAME WITH A FRACTURED WIRE MAKING IT IMPOSSIBLE TO USE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874710 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 2090141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown