BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK .035 STENT DELIVERY SYSTEM

    MDR report key: 1931584 · Received December 17, 2010

    Report

    Report Number
    3004742046-2010-00613
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    November 24, 2010
    Manufacturer
    AV-TEMECULA-VS
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE MAY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE STENT DELIVERY SYSTEM (SDS), NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. RETURN OF THE OTW OMNILINK SDS MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT CANNOT BE DETERMINED. TO ENSURE THIS IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT DISLODGED INSIDE THE SHEATH DURING DEVICE PREPARATION. THE DEVICE WAS NOT USED IN THE PATIENT. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK .035 STENT DELIVERY SYSTEM BILIARY STENT SYSTEM FGE AV-TEMECULA-VS 9112051

    Patients

    Seq Age Sex Outcome Treatment
    1