BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK .035 STENT DELIVERY SYSTEM

    MDR report key: 1982104 · Received February 8, 2011

    Report

    Report Number
    2024168-2011-00778
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 14, 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
    AZ, 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 THE DEVICE WILL NOT BE RETURNED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. IMPROPER OR INCORRECT PROCEDURE OR METHOD (INDICATION FOR USE).

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED FOR EVALUATION. 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, AND INTERACTION WITH THE LESION, ACCESSORY DEVICES, AND/OR PREVIOUSLY IMPLANTED STENTS. TO ENSURE THIS IS NOT THE RESULT OF A PRODUCT 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. THE MANUFACTURING RECORDS WERE REVIEWED FOR THIS LOT AND THERE WERE NO NON-CONFORMING MATERIAL RECORDS THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND ALL SAMPLES MET ALL MANUFACTURING CRITERIA INCLUDING STENT PLACEMENT, CRIMPED STENT OUTER DIAMETER AND STENT DISLODGEMENT FORCE. FROM THESE RECORDS, THERE IS NO INDICATION OF A LOT SPECIFIC QUALITY DEFICIENCY. AN INTERACTION WITH THE LESION/ANATOMY DURING THE ATTEMPT TO CROSS THE LESION LIKELY RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE AND LOOSENED THE STENT ON THE BALLOON. FURTHER MANIPULATION OF THE SDS DURING THE MULTIPLE ATTEMPTS TO CROSS THE LESION LIKELY CONTRIBUTED TO THE STENT ULTIMATELY DISLODGING ONTO THE GUIDE WIRE. THE SMASHING OF THE STENT WITH THE GLIDE CATHETER AND SUBSEQUENT SNARING OF THE STENT WERE BOTH TREATMENTS BASED ON THE STENT DISLODGEMENT. IN THIS CASE, THE CAUSE FOR THE NOTED FAILURE TO ADVANCE AND DISLODGEMENT OF THE STENT APPEAR TO BE RELATED TO LESION ANATOMY. IT WAS NOTED THAT THIS CASE OCCURRED IN THE RENAL ARTERY; HOWEVER, PER THE INSTRUCTIONS FOR USE(IFU), THE OMNILINK .035 SDS IS ONLY INTENDED FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VERSACORE GUIDE WIRE WAS PUT DOWN AND THEN THE RENAL ARTERY WAS PREDILATED. THE OMNILINK WOULD NOT CROSS TO THE LESION SITE AND IT WAS PULLED BACK IN ORDER TO GET ANOTHER ANGIO SHOT AND IT LOOKED LIKE IT SHOULD CROSS, SO THE ATTEMPT WAS MADE AGAIN; HOWEVER, THE OMNILINK STENT DISLODGED ONTO THE GUIDE WIRE. A BALLOON CATHETER WAS USED TO PULL THE DISLODGED STENT TO THE SHEATH IN ORDER TO SNARE THE STENT AND REMOVE IT FROM THE PATIENT. THIS WAS DIFFICULT, SO THE STENT WAS SMASHED WITH A GLIDE CATHETER (SUPPORT CATHETER) AND THEN SNARED SUCCESSFULLY. THE PATIENT WAS NOT TREATED AT THIS PROCEDURE. THE PATIENT IS TO RETURN AND WILL BE TREATED VIA THE ARM. OVERALL, THE PATIENT IS DOING WELL. THOUGH REQUESTED, NO ADDITIONAL 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-CT 9051251

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention GUIDE WIRE: VERSACORE