BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1953894 · Received January 10, 2011

    Report

    Report Number
    1058196-2011-00008
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 14, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT ALSO EXPERIENCED A HEMORRHAGIC STROKE AND RESULTANT HEADACHE THE SAME DAY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA THE (B)(4) STUDY THAT DURING A STENT ASSISTED COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM WHEN PLACING THE SECOND TO LAST COIL, AN UNKNOWN TRUFILL DCS ORBIT, THROUGH THE DISTAL END OF THE BOSTON SCIENTIFIC SL10 STR MICROCATHETER CAME OUT OF THE ANEURYSM. SLIGHT BLEEDING DUE TO RUPTURE OF THE ANEURYSM WAS OBSERVED. ADDITIONAL COILS WERE PLACED CONTINUOUSLY TO CONTROL THE BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED IMPACT TO THE PATIENT'S CONDITION. IT WAS REPORTED THAT THERE WERE NO REPORTED PRODUCT ISSUES WITH THE ENTERPRISE OR THE ORBIT COIL. THE PATIENT HAD NO REPORTED NEUROLOGICAL DEFICIT UPON EXAMINATION AND WAS IN STABLE CONDITION. THE ADVERSE EVENT WAS REPORTED TO NOT BE RELATED TO THE ENTERPRISE VRD STENT OR TO THE TRUFILL DCS ORBIT COIL. IT WAS NOT KNOWN HOW MANY TOTAL COILS WERE IMPLANTED. IT WAS REPORTED THERE WAS NO VESSEL TORTUOSITY OR CALCIFICATION. THE COIL EMBOLIZATION WAS STARTED WITH JAILED TECHNIQUE AND THEN CHANGED TO TRANS-CELL TECHNIQUE. IT IS NOT KNOWN HOW MANY COILS HAD BEEN PLACED. (B)(4): THE PRODUCT WAS NOT RETURNED FOR INSPECTION. THE LOT NUMBER OF THE ORBIT COIL THAT WAS BEING PLACED IN THE ANEURYSM WHEN THE EVENT OCCURRED IS NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. THE COIL REMAINS IMPLANTED AND THE DELIVERY SYSTEM IS NOT AVAILABLE FOR ANALYSIS. ANEURYSM RUPTURE/PERFORATION AND BLEEDING IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THIS TYPE OF PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. THESE PROCEDURES INVOLVE TREATMENT OF ANEURYSMS WHICH HAVE KNOWN VESSEL WALL WEAKNESS. BASED ON THE REPORT THAT THERE WAS DISPLACEMENT OF THE NONCORDIS MICROCATHETER THROUGH WHICH THE ORBIT WAS BEING PLACED, IT APPEARS THAT PROCEDURAL FACTORS AND ANEURYSM LOCATION/CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION OF ANY DEVICE DESIGN OR MANUFACTURING ISSUES IMPACTING THE EVENT. AS REPORTED, THE RELATIONSHIP OF THE ORBIT COIL AND THE ANEURYSM RUPTURE CANNOT BE DETERMINED. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #1058196-2011-00007 AND #1058196-2011-00008.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ENTERPRISE VRD STENT; BOSTON SCIENTIFIC SL10 STR MICROCATHETER. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT #1058196-2011-00007 AND #1058196-2011-00008.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA (B)(6) STUDY THAT DURING A STENT ASSISTED COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM WHEN PLACING THE SECOND TO LAST COIL, AN UNKNOWN TRUFILL DCS ORBIT, THE DISTAL END OF THE BOSTON SCIENTIFIC SL10 STR MICROCATHETER CAME OUT OF THE ANEURYSM. SLIGHT BLEEDING DUE TO RUPTURE OF THE ANEURYSM WAS OBSERVED. ADDITIONAL COILS WERE PLACED CONTINUOUSLY TO CONTROL THE BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED IMPACT TO THE PATIENT'S CONDITION. UPDATED INFORMATION WAS RECEIVED INDICATING AN ADDITIONAL EVENT OF HEMORRHAGIC STROKE AND HEADACHE ON THE SAME DATE AS THE ANEURYSM RUPTURE WITH NO ADDITIONAL AVAILABLE INFORMATION REGARDING THE EVENTS. IT WAS REPORTED THAT THERE WERE NO REPORTED PRODUCT ISSUES WITH THE ENTERPRISE OR THE ORBIT COIL. THE PATIENT HAD NO REPORTED NEUROLOGICAL DEFICIT UPON EXAMINATION AND WAS IN STABLE CONDITION. THE ADVERSE EVENT WAS REPORTED TO NOT BE RELATED TO THE ENTERPRISE VRD STENT OR TO THE TRUFILL DCS ORBIT COIL. IT WAS NOT KNOWN HOW MANY TOTAL COILS WERE IMPLANTED. IT WAS REPORTED THERE WAS NO VESSEL TORTUOSITY OR CALCIFICATION. THE COIL EMBOLIZATION WAS STARTED WITH JAILED TECHNIQUE AND THEN CHANGED TO TRANS-CELL TECHNIQUE. IT IS NOT KNOWN HOW MANY COILS HAD BEEN PLACED. THE LOT NUMBER OF THE ORBIT COIL THAT WAS BEING PLACED IN THE ANEURYSM WHEN THE EVENT OCCURRED IS NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. THE COIL REMAINS IMPLANTED AND THE DELIVERY SYSTEM IS NOT AVAILABLE FOR ANALYSIS. ANEURYSM RUPTURE/PERFORATION AND HEMORRHAGIC STROKE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THIS TYPE OF PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. THESE PROCEDURES INVOLVE TREATMENT OF ANEURYSMS WHICH HAVE KNOWN VESSEL WALL WEAKNESS. BASED ON THE REPORT THAT THERE WAS DISPLACEMENT OF THE NONCORDIS MICROCATHETER THROUGH WHICH THE ORBIT WAS BEING PLACED, IT APPEARS THAT PROCEDURAL FACTORS AND ANEURYSM LOCATION/CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION OF ANY DEVICE DESIGN OR MANUFACTURING ISSUES IMPACTING THE EVENT. AS REPORTED, THE RELATIONSHIP OF THE ORBIT COIL AND THE ANEURYSM RUPTURE CANNOT BE DETERMINED. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #1058196-2011-00007 AND #1058196-2011-00008.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PATIENT WAS IN A CLINICAL STUDY (B)(4). THE REPORT INDICATED THAT DURING A STENT ASSISTED COIL EMBOLIZATION, THE PHYSICIAN USED A PLANNED JAILED TECHNIQUE WITH THE ENTERPRISE VRD STENT. THE TARGET LESION WAS A BA-TOP WHICH WAS REPORTED TO BE NOT CALCIFIED AND TORTUOUS. THE PHYSICIAN THEN CHANGED FROM A JAILED TECHNIQUE TO A TRANS-CELL TECHNIQUE. WHILE PLACING THE SECOND TO LAST COIL WHICH WAS AN UNKNOWN TRUFILL DCS ORBIT, THE DISTAL END OF THE BOSTON SCIENTIFIC SL10 STR MICROCATHETER CAME OUT OF THE ANEURYSM. SLIGHT BLEEDING OF THE ANEURYSM WAS OBSERVED. ADDITIONAL COILS WERE PLACED CONTINUOUSLY TO CONTROL THE BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED IMPACT TO THE PATIENT'S CONDITION. THE PATIENT HAD NO REPORTED NEUROLOGICAL DEFICIT UPON EXAMINATION AND WAS IN STABLE CONDITION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE BLEEDING EVENT WAS CONSIDERED A RUPTURE OF THE ANEURYSM. THE ADVERSE EVENT WAS REPORTED TO NOT BE RELATED TO THE ENTERPRISE VRD STENT OR TO THE TRUFILL DCS ORBIT COIL. IT WAS NOT KNOWN HOW MANY TOTAL COILS WERE IMPLANTED. IT WAS NOT KNOWN IF THE EVENT WAS RELATED TO THE STUDY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R