BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK STENT DELIVERY SYSTEM

    MDR report key: 1982115 · Received February 8, 2011

    Report

    Report Number
    2024168-2011-00779
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. INCORRECT ANATOMY. STENT FRACTURE CAN BE A RESULT OF, BUT NOT LIMITED TO, STENT MATERIAL, POST DILATATION TECHNIQUE, ANATOMICAL MOTION RESULTING IN STRESS/FATIGUE OF THE STENT MATERIAL AND/OR INTERACTION WITH OTHER DEVICE POST DEPLOYMENT. THE STENT FRACTURE WAS NOT NOTED AT THE TIME OF STENT IMPLANT WHICH WAS FOUR YEARS PRIOR. IN THIS CASE, A REQUEST WAS MADE TO GET A COPY OF THE CINE OR PICTURE OF THE FRACTURED/RESTENOSIS IN THE STENT; HOWEVER, IT WAS REPORTED THAT THE HOSPITAL TRADITIONALLY WILL NOT ALLOW ANY IMAGES TO BE TAKEN OUTSIDE OF HOSPITAL. ADDITIONALLY, IT WAS REPORTED FROM THE TERRITORY MANAGER THAT LOOKING AT THE FILMS, THE STENT WAS NOT BROKEN IN TWO PIECES. A CONCLUSIVE CAUSE FOR THE REPORTED STENT FRACTURE AND REPORTED RE-STENOSIS COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN OMNILINK STENT IMPLANTED IN THE BRACHIOCEPHALIC ARTERY APPROXIMATELY 4 YEARS AGO AND IT APPEARED TO HAVE FRACTURED (NOT IN TWO PIECES) AND RE-STENOSED. A NON-ABBOTT 6.0 X 22 MM COVERED STENT WAS IMPLANTED FOR TREATMENT AND POST-DILATATION WAS PERFORMED WITH AN 8.0 X 20 MM BALLOON CATHETER. THE PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK STENT DELIVERY SYSTEM BILIARY STENT SYSTEM FGE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention