BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 21746491 · Received April 1, 2025

    Report

    Report Number
    2024168-2025-03380
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    February 7, 2025
    Report Date
    April 1, 2025
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIO
    UDI-DI
    08717648114724
    PMA / PMN Number
    P110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED ACTIVATION FAILURE WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. THE STENT SHEATH WAS SEPARATED 20 MILLIMETERS (MM) DISTAL FROM THE OM- STENT SHEATH BOND. THE STENT IMPLANT WAS EXPOSED 3MM FROM THE DISTAL END OF THE SHEATH. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. AS THERE WAS NO DAMAGE NOTED TO THE DEVICE DURING THE INSPECTION PRIOR TO USE, THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT THE DEVICE WAS BENT IN THE MILDLY TORTUOUS, MILD TO MODERATELY CALCIFIED ANATOMY WITH REALLY SMALL ARTERIES RESULTING IN PREVENTING THE SHAFT LUMENS FROM MOVING FREELY; THUS RESULTING IN THE REPORTED ACTIVATION/DEPLOYMENT FAILURE. INTERACTION/MANIPULATION OF THE COMPROMISED DEVICE RESULTED IN THE NOTED EXPOSED STENT IMPLANT AND ULTIMATELY RESULTED IN THE NOTED SHEATH SEPARATION CONTRIBUTING TO THE REPORTED DIFFICULTIES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A CROSS OVER PROCEDURE TO TREAT THE MILDLY TORTUOUS, MILD TO MODERATELY CALCIFIED EXTERNAL ILIAC ARTERY AND THE LEFT SUPERFICIAL FEMORAL ARTERY. A 6.0X40MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) WAS FIRST IMPLANTED SUCCESSFULLY IN THE EXTERNAL ILIAC ARTERY. THEN ANOTHER 6.0X40MM ABSOLUTE PRO SES WAS ATTEMPTED TO BE IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY; HOWEVER, THE STENT COMPLETELY FAILED TO DEPLOY. THEREFORE, ANOTHER SAME SIZE ABSOLUTE PRO SES WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, FAILED. THERE WAS NO OTHER STENT IMPLANTED. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND THE STENT SHEATH OF THE ABSOLUTE PRO SES [LOT#4082762] WAS SEPARATED 15 MILLIMETERS (MM) DISTAL FROM THE OM- STENT SHEATH BOND. THE STENT SHEATH OF THE ABSOLUTE PRO SES [LOT#4072461] WAS SEPARATED 20 MILLIMETERS (MM) DISTAL FROM THE OM- STENT SHEATH BOND. THE STENT WAS EXPOSED 3MM FROM THE DISTAL END OF THE SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2698176 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM STENT, ILIAC NIO ABBOTT VASCULAR 1011915-040 4072461 08717648114724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown