BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 3033214 · Received April 3, 2013

    Report

    Report Number
    2024168-2013-01942
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    August 16, 2012
    Report Date
    March 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF HYPERSENSITIVITY IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT AS LISTED IN THE ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE ADDITIONAL ABSOLUTE PRO DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE ABSOLUTE PRO STENTS AND A NON-ABBOTT STENT WERE IMPLANTED ON (B)(6) 2012. SOMETIME AFTER THE PROCEDURE, IT WAS THOUGHT THAT THE PATIENT WAS EXPERIENCING AN ALLERGIC REACTION SHORTLY AFTER THE PROCEDURE, WITH HISTAMINE-LIKE SYMPTOMS. THE PATIENT WAS PLACED ON STEROIDS FOR TREATMENT. AN ALLERGY TEST WAS PERFORMED WHICH CONFIRMED THAT THE PATIENT WAS ALLERGIC TO NICKEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136450 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIO AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention STENT: CORDIS SMART STENT