BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION¿

    MDR report key: 24292279 · Received February 9, 2026

    Report

    Report Number
    2024168-2026-00525
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 9, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648157950
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED SHAFT SEPARATION WAS CONFIRMED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. 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 REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THE DEVICE INTERACTED WITH THE HEAVILY CALCIFIED LESION DURING ADVANCEMENT. CONTINUED HANDLING AND/OR MANIPULATION OF THE DEVICE DURING THE REPORTED DIFFICULTIES LIKELY RESULTED IN THE REPORTED SHAFT SEPARATION. 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. CORRECTIONS: D4 - LOT #: UPDATED FROM 5080541 TO 5070141. D4 - EXPIRATION DATE: UPDATED FROM 7/24/2028 TO 6/23/2028. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4) TO (B)(4). H4 - DEVICE MFR DATE: UPDATED FROM 7/25/2025 TO 6/24/2025.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED VESSEL. A XIENCE XPEDITION 3.00X48MM WAS INSERTED. HOWEVER, THE STENT WAS UNABLE TO CROSS THE LESION, AND THE PROXIMAL SHAFT RUPTURED AND BROKE. THE DEVICE WAS SUCCESSFULLY REMOVED, AND NO PORTIONS OF THE DEVICE REMAINED IN THE ANATOMY. AN ADDITIONAL XIENCE XPEDITION WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158043 XIENCE XPEDITION¿ DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1070300-48 5070141 08717648157950

    Patients

    Seq Age Sex Outcome Treatment
    1