BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 3112380 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03035
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    July 1, 2010
    Report Date
    April 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED AS ONE YEAR FROM START OF STUDY. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF RESTENOSIS IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT AS LISTED IN THE ABSOLUTE PRO .035 PERIPHERAL 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 WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. THE OMNILINK ELITE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. IT WAS REPORTED THAT A PROSPECTIVE, NON-RANDOMIZED, MULTI-CENTER, MULTI-NATIONAL, MONITORED TRIAL CONDUCTED AT 12 HOSPITALS IN (B)(6) AND 11 HOSPITALS IN (B)(6), IDENTIFIED A TOTAL OF 325 PATIENTS WHO RECEIVED UNKNOWN ABSOLUTE PRO STENTS AND UNKNOWN OMNILINK ELITE STENTS IMPLANTED IN TRANS-ATLANTIC INTER-SOCIETY CONSENSUS (TASC) A/B AND TASC C/D ILIAC LESIONS BETWEEN JULY 2009 AND SEPTEMBER 2010. THE 12-MONTH PRIMARY PATENCY RATE WAS 92% IN LESIONS TREATED WITH THE OMNILINK ELITE STENTS AND 96% IN LESIONS TREATED WITH THE ABSOLUTE PRO STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212322 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other