BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK .035 STENT DELIVERY SYSTEM

    MDR report key: 2003488 · Received March 1, 2011

    Report

    Report Number
    2024168-2011-01263
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF PERFORATION IS LISTED IN THE PRODUCT INSTRUCTION FOR USE (IFU) AS KNOWN POTENTIAL ADVERSE EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. AS IT WAS REPORTED THAT THE OTW OMNILINK WAS USED TO TREAT THE RIGHT COMMON ILIAC ARTERY, IT SHOULD BE NOTED THAT THE PRODUCT IFU STATES: THE OMNILINK .035 BILIARY STENT SYSTEM IS INTENDED FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE. IN THIS CASE, IT COULD NOT BE DETERMINED IF THE OFF-LABEL USE CAUSED OR CONTRIBUTED TO THE REPORTED PERFORATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF AN OMNILINK 9X28X80 IN A MILDLY CALCIFIED AND HEAVILY TORTUOUS RIGHT COMMON ILIAC ARTERY, A PERFORATION WAS NOTED AT THE EDGE OF THE STENT. THE PERFORATION WAS TREATED WITH A NON-ABBOTT DEVICE. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK .035 STENT DELIVERY SYSTEM BILIARY STENT SYSTEM FGE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention