BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 3020096 · Received March 25, 2013

    Report

    Report Number
    2024168-2013-01708
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXCESSIVE FORCE. THE DEVICE WAS RETURNED FOR ANALYSIS. THE RETRACTION PROBLEM WAS ABLE TO BE CONFIRMED; HOWEVER, THE STENT SEPARATION WAS UNABLE TO BE CONFIRMED AS THE STENT WAS NOT RETURNED. THE DIFFICULTY DEPLOYING THE STENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER POSITIONING A NON-ABBOTT EMBOLIC PROTECTION FILTER PROXIMAL TO THE LESION, A 9.0MM X 100MM X 80CM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT RESISTANCE, VIA FEMORAL ACCESS, TO A NON-HEAVILY CALCIFIED LESION IN THE NON-TORTUOUS DISTAL EXTERNAL RIGHT ILIAC ARTERY. WHEN ROLLING THE THUMBWHEEL BACK TO RELEASE THE STENT, THE THUMBWHEEL BECAME STUCK AND COULD NOT BE MOVED AT ALL, AND HALF OF THE DISTAL END OF THE STENT WAS RELEASED IN THE ANATOMY. THE ABSOLUTE PRO SESS WAS THEN PULLED BACK WITH FORCE WITH THE INTENTION OF RELEASING THE REMAINING PROXIMAL END OF THE STENT FROM THE SHEATH, HOWEVER, THE DISTAL HALF OF THE STENT SEPARATED AND WAS LEFT EXPANDED IN PART OF THE LESION. THE ABSOLUTE PRO SESS, WITH THE PROXIMAL HALF OF THE STENT STILL REMAINING INSIDE OF THE SHEATH, WAS WITHDRAWN FROM THE ANATOMY WITHOUT ANY RESISTANCE. ANOTHER SAME SIZE ABSOLUTE PRO SESS WAS ADVANCED AND DEPLOYED INSIDE OF THE PARTIAL/SEPARATED STENT PIECE, COVERING BOTH THE STENT PIECE AND THE ENTIRE TARGET LESION WITHOUT ISSUE. THE FILTER WAS WITHDRAWN AND INSPECTED; NO STENT DEBRIS OR PARTICLES WERE FOUND IN THE FILTER. THE PARTIAL STENT AND NEWLY DEPLOYED STENT WERE CONFIRMED VIA ANGIOGRAM TO BE COMPLETELY APPOSED TO THE VESSEL WALL WITHIN THE TARGETED LESION. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121781 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIO AV-TEMECULA-CT 2071961

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention EMBOLIC PROTECTION: SPIDER