BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK .018 STENT DELIVERY SYSTEM

    MDR report key: 2203683 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05689
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS INCLUDING, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREP, INTERACTION WITH ACCESSORY DEVICES, INTERACTION WITH THE LESION, TORTUOUS ANATOMY, OR HEAVY CALCIFICATIONS. TO ENSURE THIS IS NOT THE RESULT OF A PRODUCT DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR PROPER STENT PLACEMENT AND STENT DAMAGE, AND ARE 100% DIMENSIONALLY INSPECTED FOR CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, SAMPLES ARE REMOVED FROM EACH LOT FOR DESTRUCTIVE STENT DISLODGEMENT TESTING. IN THIS CASE, IT WAS REPORTED THAT THE STENT DISLODGED DURING ADVANCEMENT AROUND A BEND, SUGGESTING THAT ANATOMICAL CHALLENGES CONTRIBUTED TO THE DISLODGEMENT. AS IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERIOR MESENTERIC ARTERY (SMA), IT SHOULD BE NOTED THAT THE OTW OMNILINK AS LISTED IN THE PRODUCT INSTRUCTION FOR USE IS INDICATED FOR USE IN PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE. IN THIS CASE, IT COULD NOT BE DETERMINED IF THE OFF-LABEL USE CONTRIBUTED TO THE REPORTED DISLODGEMENT. THE LOT HISTORY RECORD FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. THE REPORTED STENT DISLODGEMENT APPEARS TO BE RELATED TO DIFFICULTIES DURING THE PROCEDURE AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT IN A BEND IN THE SUPERIOR MESENTERIC ARTERY (SMA) AND THE OMNILINK STENT DISLODGED FROM THE BALLOON. THE DILATATION CATHETER WAS REINTRODUCED INTO THE STENT AND THE STENT WAS EXPANDED AND IMPLANTED IN THE SMA, AN UNINTENDED SITE. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK .018 STENT DELIVERY SYSTEM BILIARY STENT SYSTEM FGE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention