BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XTRASOFT ORBIT GALAXY DETACHABLE COIL

    MDR report key: 1852532 · Received October 4, 2010

    Report

    Report Number
    3007628272-2010-50005
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 8, 2010
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A STENT ASSISTED COIL EMBOLIZATION OF A PARACLINOID ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY, AFTER DETACHMENT OF THE SECOND COIL, A 2.5X3.5 ORBIT GALAXY, THE TAIL OF THE COIL WAS BETWEEN THE STENT AND THE VESSEL WALL. THERE WAS NO RESIDUAL FILLING IN THE ANEURYSM SAC. THE (B)(6) FEMALE PRESENTED WITH AN ASYMPTOMATIC PARACLINOID ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY. IN ADDITION, THE PATIENT HAD A BASILAR TIP ANEURYSM WHICH WAS COILED WITH COMPLETE OBLITERATION. A 4.5X22 ENTERPRISE VRD WAS PLACED ACROSS THE NECK OF THE ANEURYSM FOLLOWED BY PLACEMENT OF A 3X6 COMPLEX FILL ORBIT COIL FOR FRAMING. THIS WAS FOLLOWED BY PLACEMENT OF THE 2.5X3.5 COMPLEX XTRASOFT ORBIT GALAXY. ALL LABELING INSTRUCTIONS WERE FOLLOWED FOR FILLING THE SYRINGE AND DETACHMENT OF THE COIL WITH THE SYRINGE. THE SAME SYRINGE WAS UTILIZED WITH OTHER PRODUCTS. PRIOR TO DETACHMENT THE COIL THE POSITION OF THE COIL WAS VERIFIED WITH FLUOROSCOPY AND WAS IN GOOD POSITION, FULLY WITHIN THE ANEURYSM. THERE WERE NO ISSUES POSITIONING THE COIL IN THE ANEURYSM OR DURING DETACHMENT, OR ENTANGLEMENT WITH THE FIRST COIL. HOWEVER, CONSTANT FLUOROSCOPY WAS NOT CONDUCTED UNTIL AFTER THE COIL WAS DETACHED. NO ADDITIONAL MANIPULATION OCCURRED DURING DETACHMENT, AND THE COIL DELIVERY SYSTEM DID NOT MOVE DURING THE EVENT. THE COIL REMAINS IMPLANTED IN THE PATIENT AND THE DELIVERY SYSTEM IS NOT AVAILABLE 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 13500032 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DEVICE HISTORY RECORDS REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION TEST RESULTS TEST. PREVENTIVE MAINTENANCE RECORDS FOR COIL LOADING MACHINE WAS REVIEWED, AND IT WAS FOUND THAT THE PREVENTIVE MAINTENANCE WAS EXECUTED DURING THE ESTABLISHED TIME PERIOD. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE PREVENTIVE MAINTENANCE DATES. BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS THERE ARE NO IDENTIFIED MANUFACTURING ISSUES RELATED TO THE REPORTED EVENT. IT IS POSSIBLE THAT CLINICAL/PROCEDURAL FACTORS MAY HAVE IMPACTED THE EVENT; HOWEVER, WITH REVIEW OF THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ENTERPRISE STENT, ORBIT COIL, DCS SYRINGE, AND MICROCATHETER. THE SYRINGE LOSS PRESSURE AFTER THE COIL DETACHED. ALL LABELING INSTRUCTIONS WERE FOLLOWED FOR FILLING THE SYRINGE AND DETACHMENT OF THE COIL WITH THE SYRINGE. THE SAME SYRINGE WAS UTILIZED WITH OTHER PRODUCTS. THERE WERE TWO DIFFERENT CASES WITH EACH HAVING ONE ORBIT GALAXY COIL. THE PATIENT PRESENTED WITH AN ASYMPTOMATIC PARACLINOID ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY. IN ADDITION, THE PATIENT HAD A BASILAR TIP ANEURYSM WHICH WAS COILED WITH COMPLETE OBLITERATION .3MM LT. OPHTHALMIC SEGMENT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A STENT ASSISTED ANEURYSM COIL EMBOLIZATION, A 4.5X22 ENTERPRISE VRD WAS PLACED AND A 3X6 COMPLEX FILL ORBIT COIL WAS PLACED FOR FRAMING. AFTER DETACHMENT OF THE SECOND COIL, A 2.5X3.5 COMPLEX XTRASOFT GALAXY, THE TAIL OF THE COIL WAS BETWEEN THE STENT AND THE VESSEL WALL. THERE WAS NO RESIDUAL FILLING IN THE ANEURYSM SAC. PRIOR TO DETACHMENT, THE COIL THE POSITION OF THE COIL WAS VERIFIED WITH FLUOROSCOPY AND WAS IN GOOD POSITION, FULLY WITHIN THE ANEURYSM. THERE WERE NO ISSUES POSITIONING THE COIL IN THE ANEURYSM OR DURING DETACHMENT, OR ENTANGLEMENT WITH THE FIRST COIL. HOWEVER, CONSTANT FLUOROSCOPY WAS NOT CONDUCTED UNTIL AFTER THE COIL WAS DETACHED. NO ADDITIONAL MANIPULATION OCCURRED DURING DETACHMENT, AND THE COIL DELIVERY SYSTEM DID NOT MOVE DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XTRASOFT ORBIT GALAXY DETACHABLE COIL ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC 13500032

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening