BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 3851596 · Received June 5, 2014

    Report

    Report Number
    2024168-2014-03608
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 13, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED PREMATURE DEPLOYMENT WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS PREMATURE DEPLOYMENT REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVAL OF THE ABSOLUTE PRO SELF-EXPANDING STENT DELIVERY SYSTEM (SES) FROM THE PROTECTIVE HOOP, WITHOUT RESISTANCE, THE STENT WAS PARTIALLY DEPLOYED. THE DEVICE WAS SET ASIDE AND NOT USED. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER SES WAS USED WITHOUT REPORTED ISSUES. THERE WAS NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329375 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 1050361

    Patients

    Seq Age Sex Outcome Treatment
    1