BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 1973976 · Received January 31, 2011

    Report

    Report Number
    1058196-2011-00047
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    November 30, 2010
    Report Date
    January 20, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15158719 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 35 UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. THE NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED VIA THE (B)(4) ENTERPRISE POST MARKET STUDY THAT DURING AN ENTERPRISE VRD ASSISTED COIL EMBOLIZATION OF A PCOM ANEURYSM THE 8TH COIL, AN 8X24 COMPLEX FILL TRUFILL ORBIT UNRAVELED AND WAS WITHDRAWN SUCCESSFULLY FROM THE PATIENT WITH THE COIL ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO ADVERSE EVENT WITH THE PROCEDURE COMPLETED USING OTHER COILS. THERE WAS NO RESISTANCE/FRICTION WITH ADVANCEMENT THROUGH THE MICROCATHETER. THERE WERE NO DAMAGES NOTED ON THE MICROCATHETER AND THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO CAUSALITY WITH THE ENTERPRISE. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THE PROCEDURAL FACTORS, DEVICE MANIPULATION PRIOR TO THE STRETCHING OF THE COIL. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15158719 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LIMITED PROCEDURAL INFORMATION AND WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING POSSIBLE CONTRIBUTING FACTORS. WITH REVIEW OF THE DEVICE HISTORY RECORDS, THERE IS NO INDICATION OF ANY RELATED MANUFACTURING ISSUES.

    Description of Event or Problem · 1

    THE REPORT FROM A CLINICAL STUDY (B)(4) FOR PATIENT WITH ID (B)(4) INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH THE ENTERPRISE VRD (ENC452812) FOR AN UNRUPTURED ANEURYSM OF THE (P-COM) POSTERIOR COMMUNICATING ARTERY. THE ORBIT 638CF0824 WHICH WAS USED AS THE 8TH COIL WAS UNRAVELED AND WITHDRAWN SUCCESSFULLY FROM THE PATIENT'S BODY. THERE WAS NO ADVERSE EVENT. TWO OTHER COILS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO CAUSALITY WITH THE ENTERPRISE. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES, AND THERE WERE NO KINKS IN THE (MC) MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE, SINCE IT WAS NOT DAMAGED. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE (COIL FRACTURE, SEPARATED, ETC), AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS STABLE, AND THE ANEURYSM WAS 90% OBLITERATED. MEDICATIONS GIVE PRE-PROCEDURE CONSISTED OF CLOPIDOGREL, CILOSTAZOL, DURING THE PROCEDURE HEPARIN, AND POST-PROCEDURE ARGATROBAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15158719

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR MICROCATHETER, COILS AND STENT.