BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 8264241 · Received January 21, 2019

    Report

    Report Number
    2024168-2019-00466
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    November 20, 2018
    Report Date
    January 21, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    UDI-DI
    08717648175633
    PMA / PMN Number
    P110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED COMPLAINT WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE INVESTIGATION DETERMINED THE LOOSE MATERIAL IN THE SEALED HEADER BAG APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSPECTION OF A 7.0 X 60MM ABSOLUTE PRO VASCULAR DEVICE (CONSIGNMENT RETURN PRODUCT) AT A DISTRIBUTION CENTER, SEVERAL SMALL PIECES OF STRING LIKE WHITE FOREIGN MATERIAL WERE FOUND INSIDE THE STERILE POUCH. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS INDICATED THE STRANDS OF CLEAR MATERIAL REMOVED FROM THE SEALED POUCH WERE KYNAR (POLYVINYLIDENE FLUORIDE) FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56824 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIO AV-TEMECULA-CT 6102861 08717648175633

    Patients

    Seq Age Sex Outcome Treatment
    1