BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 2851617 · Received November 29, 2012

    Report

    Report Number
    2024168-2012-07568
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE OTHER ABSOLUTE PRO DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE 7/80 MM X 135 CM ABSOLUTE PRO STENT WAS IMPLANTED WITHOUT ISSUE IN THE TARGET VESSEL. ANOTHER 7/30 MM X 135 CM ABSOLUTE PRO SELF EXPANDING STENT DELIVERY SYSTEM (SESS) WAS ADVANCED TO BE PLACED DISTALLY; HOWEVER, BECAME CAUGHT ON THE DISTAL PORTION OF THE IMPLANTED STENT. THE IMPLANTED STENT BECAME STRETCHED DISTALLY, 2 CM. THE SESS WAS REMOVED WITHOUT ISSUE. A NON-ABBOTT STENT WAS THEN USED TO TREAT THE DISTAL LESION SUCCESSFULLY AND TO OVERLAP THE STRETCHED PORTION OF THE IMPLANTED STENT. THE ABSOLUTE SESS THAT WAS UNABLE TO CROSS WAS THEN USED IN ANOTHER SECTION OF THE SFA SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIO AV-TEMECULA-CT 2040261

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR