BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 3895336 · Received June 25, 2014

    Report

    Report Number
    2024168-2014-04089
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED INACCURATE DELIVERY COULD NOT BE CONFIRMED BECAUSE THE STENT HAD ALREADY BEEN DEPLOYED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY. THE 10.0MMX30MMX135CM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS SUCCESSFULLY ADVANCED TO THE LESION; HOWEVER, DURING DEPLOYMENT THE STENT IMPLANT JUMPED DISTAL TO THE TARGET LESION AND WAS DEPLOYED PARTIALLY COVERING THE TARGET LESION AND PARTIALLY COVERING HEALTHY TISSUE. THERE WAS NO REPORTED ISSUE WITH THE THUMBWHEEL. THE PHYSICIAN IS UNCLEAR WHY THE STENT JUMPED FORWARD DURING DEPLOYMENT. AN UNPLANNED NON-ABBOTT STENT IMPLANT WAS DEPLOYED TO TREAT THE UNTREATED PORTION OF THE TARGET LESION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371246 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIO AV-TEMECULA-CT 2011761

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention