BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 22720751 · Received August 5, 2025

    Report

    Report Number
    2024168-2025-08080
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 13, 2025
    Report Date
    December 2, 2025
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIO
    UDI-DI
    08717648115103
    PMA / PMN Number
    P110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    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

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DEVICE MARKINGS / LABELLING PROBLEM WAS ABLE TO BE CONFIRMED. THE REPORTED PREMATURE ACTIVATION (STENT PARTIALLY REMOVED FROM THE RELEASE SHEATH BEFORE USE) WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE (STENT IMPLANT WAS DEPLOYED AND NOT RETURNED). PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE 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 LEVEL PRODUCT QUALITY ISSUE. A WHERE SHIP/EXPORT REPORT WAS RUN WHICH CONFIRMED BOTH THE LOT LISTED ON THE LABEL (6MM X 80MM AND LOT# 3120761) AND THE LOT LISTED ON THE HANDLE (6MM X 40MM AND LOT# 4121761) WERE SHIPPED TO THE HÔPITAL AMBROISE-PARÉ ACCOUNT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS INADVERTENT MISHANDLING OF THE DEVICE LIKELY RESULTED IN CAUSING THE DISTAL SHEATH TO SLIGHTLY RETRACT FROM THE BASE OF THE TIP AND INADVERTENTLY PREMATURELY DEPLOY THE STENT. THE REPORTED DEVICE MARKINGS / LABELLING PROBLEM (HANDLE/LAUNCHER OF THE DEVICE HAD A DIFFERENT SIZE AND LOT NUMBER THAN THE LABEL) LIKELY OCCURRED DURING INADVERTENT MISHANDLING AT THE HOSPITAL. BASED ON THE REPORTED INFORMATION AND 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. H6: MEDICAL DEVICE PROBLEM CODE 4051 WAS REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE OF THE 6X80 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS), IT WAS NOTED THAT THE HANDLE/LAUNCHER OF THE DEVICE HAD A DIFFERENT SIZE AND LOT NUMBER (LOT 3120761, 6X40MM). THEREFORE THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW 6X80 MM ABSOLUTE PRO SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT IT SHOULD BE NOTED THAT THE STENT WAS EXPOSED FROM THE SHEATH PRIOR TO USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2642448 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM STENT, ILIAC NIO ABBOTT VASCULAR 1011921-080 3120761 08717648115103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown