BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX HERCULINK ELITE STENT SYSTEM

    MDR report key: 2112091 · Received June 2, 2011

    Report

    Report Number
    2024168-2011-03855
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE STENT DELIVERY SYSTEM (SDS) FOUND BLOOD IN THE GUIDE WIRE LUMEN, INFLATION LUMEN AND BALLOON, CONSISTENT WITH BEING ADVANCED OVER THE GUIDE WIRE AND A POSSIBLE LEAK INTO THE INFLATION LUMEN WHILE IN THE ANATOMY. THERE WAS NO CONTRAST VISIBLE. THE BALLOON WAS LOOSELY FOLDED, CONSISTENT WITH BEING INFLATED. THE INNER AND OUTER MEMBERS WERE TORN AT THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 2CM. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE INNER DIAMETER OF THE GUIDE WIRE LUMEN WAS MEASURED WITH A .0150 INCH MANDREL. THERE WAS RESISTANCE BETWEEN THE MARKERS, LIKELY DUE TO THE INNER MEMBER BEING COMPROMISED DURING THE DIFFICULTY REMOVING IT FROM THE WIRE. DURING FUNCTIONAL TESTING, A NEW .014 INCH GUIDE WIRE WAS ADVANCED THROUGH THE GUIDE WIRE LUMEN. THERE WAS RESISTANCE NOTED AS THE GUIDE WIRE ADVANCED BETWEEN THE BALLOON MARKERS. THE SDS WAS PRESSURIZED USING A NEW INDEFLATOR FILLED WITH WATER. WATER LEAKED OUT OF THE TEAR IN THE GUIDE WIRE EXIT NOTCH AND FROM THE TIP. A CONCLUSIVE CAUSE FOR THE DIFFICULTY REMOVING THE SDS COULD NOT BE DETERMINED; HOWEVER, THE TEAR NOTED AT THE GUIDE WIRE EXIT NOTCH AND EXTENDING INTO THE INFLATION LUMEN IS CONSISTENT WITH THE GUIDE WIRE AND STENT DELIVERY SYSTEM BEING PULLED IN OPPOSITE DIRECTIONS. THE GUIDE WIRE TEARING INTO THE LUMEN OF THE CATHETER ALSO LIKELY CONTRIBUTED TO THE REPORTED RESISTANCE DURING ADVANCEMENT AND REMOVAL OF THE SDS. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: BALANCE HEAVYWEIGHT GUIDE WIRE (BHW). INFLATION: COOK. SHEATH: CORDIS 6F. THE BALANCE HEAVYWEIGHT GUIDE WIRE (BHW) IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT OF THE HERCULINK ELITE OVER THE BALANCE HEAVY-WEIGHT (BHW) GUIDE WIRE TO THE TARGET LESION IN THE MILDLY CALCIFIED, RESTENOSED, PROXIMAL INFERIOR MESENTERIC ARTERY, THE BHW MOVED BACK SLIGHTLY AND COILED. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THE HERCULINK ELITE. THE BHW WAS REINTRODUCED INTO THE TARGET LESION AND THE HERCULINK ELITE WAS DEPLOYED. AFTER THE HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) HAD BEEN RETRACTED OVER THE BHW ABOUT 30 CM, RESISTANCE WAS FELT SO THE SDS AND BHW WERE REMOVED TOGETHER. IT WAS THEN NOTED THAT THE BHW HAD BROKEN IN HALF AS THE PROXIMAL HALF WAS LAYING OUTSIDE OF THE PATIENT AND APPROXIMATELY 5 CM OF THE DISTAL SEGMENT WAS PROTRUDING FROM THE GUIDE WIRE EXIT NOTCH OF THE SDS. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX HERCULINK ELITE STENT SYSTEM BILIARY STENT SYSTEM FGE AV-TEMECULA-CT 8101651

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR