BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XTRASOFT ORBIT GALAXY DETACHABLE COIL

    MDR report key: 3934737 · Received July 15, 2014

    Report

    Report Number
    1226348-2014-30045
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    April 12, 2013
    Report Date
    June 24, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 8/7/2014. THERE HAD BEEN A COIL COMPACTION TREATED WITH COIL EMBOLIZATION OF THE SAME ANEURYSM ON (B)(6) 2013; HOWEVER, THE TYPE/BRAND OF COILS USED FOR THIS PROCEDURE WAS UNKNOWN. NO ADDITIONAL INFORMATION REGARDING THAT EVENT OR PROCEDURE COULD BE OBTAINED. IT WAS REPORTED THAT THE PATIENT EXHIBITED SYMPTOMS OF COIL COMPACTION/RECANALIZATION ON (B)(6) 2014, AND TREATMENT/ANGIOGRAPHY WAS PERFORMED ON (B)(6) 2014 INSTEAD OF (B)(6) 2014 AS PREVIOUSLY REPORTED. THE PHYSICIAN CONCLUDED THAT THE COIL COMPACTION AND RECANALIZATION HAD OCCURRED NATURALLY, AND WAS NOT RELATED TO THE COILS OR THE EMBOLIZATION PROCEDURE. NO ADDITIONAL INFORMATION COULD BE OBTAINED. AS REPORTED VIA THE (B)(4) STUDY, APPROXIMATELY 2 YEARS AND AGAIN 3 YEARS AFTER THE INDEX PROCEDURE, AN (B)(6) FEMALE PATIENT WITH A HISTORY OF CARDIOVASCULAR DISEASE AND PREVIOUS COIL EMBOLIZATION TO THE LEFT INTERNAL CAROTID ARTERY WAS TREATED FOR ANEURYSM RECANALIZATION DUE TO COIL COMPACTION. AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT UNDERWENT STENT ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED LEFT PARASELLAR ANEURYSM WITH AN ENTERPRISE VRD (ENC452212/014224292) AND PRESIDIO 5MMX17CM (PC4100517-30/F62853), CASHMERE 4MMX8CM (CRC140408-30/G12500) X 2, CASHMERE 5MMX12CM (CRC140512-30/G12444), CASHMERE 4MMX6CM (CRC140406-30/G11782), CACHMERE 4MMX6CM (CRC140406-30/G12282), GALAXY 4MMX8MM (640CX0408/13500145), GALAXY 3.5MMX7.5MM (640CX3575/13500179), GALAXY 3.5MMX7.5MM (640CX3575/13500245), AND V-TRACK MICROPLEX X 4. PRE-INDEX PROCEDURE OCCLUSION RATE WAS 50%, PARENT VESSEL WAS 4.3MM PROXIMAL AND 3.5MM DISTAL, NECK TO SAC RATIO WAS 5.5MM: 15.1MM (MAXIMUM DIAMETER 15.5MM). POST-PROCEDURE OCCLUSION RATE WAS 96%, PARENT VESSEL WAS 4.1MM PROXIMAL AND 3.5MM DISTAL AND NECK TO SAC RATIO WAS UNCHANGED. ONE YEAR AFTER THE INDEX PROCEDURE, THE OCCLUSION RATE WAS 90%, VESSEL WAS 4.6MM PROXIMAL AND 3.7MM DISTAL, AND NECK TO SAC RATION WAS 5.7MM;15.1MM (MAXIMUM DIAMETER 15.5MM). TWO YEARS AFTER THE INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH COIL COMPACTION, AND WAS TREATED WITH COIL EMBOLIZATION WITH USE OF UNSPECIFIED COILS. NO ADDITIONAL INFORMATION ABOUT THAT PROCEDURE COULD BE OBTAINED. THREE YEARS AFTER THE INDEX PROCEDURE, THE PATIENT WAS AGAIN DIAGNOSED WITH COIL COMPACTION AND RECANALIZATION, WITH AN OCCLUSION RATE WAS 70%. AT THAT TIME, VESSEL WAS 4.1MM PROXIMAL AND 3.6MM DISTAL, NECK TO SAC RATIO WAS 6.5MM;19.4MM (MAXIMUM DIAMETER 20.0MM). REPEAT COIL EMBOLIZATION, ASSISTED WITH ENTERPRISE VRD (ENC452212/014224292), WAS RE-CONDUCTED APPROXIMATELY ONE MONTH LATER. THE PROCEDURE WAS SUCCESSFUL WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCTS USED DURING THE INDEX PROCEDURE WERE NEW AND WERE STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. THE ENTERPRISE HAD BEEN FULLY EXPANDED WITH GOOD WALL APPOSITION, AND IT WAS REPORTED THAT THE VRD WAS SUCCESSFULLY RETAINING THE COILS INSIDE THE TARGET ANEURYSM AT THE TIME OF THE COIL COMPACTION. THE PHYSICIAN CONCLUDED THAT THE COIL COMPACTION AND RECANALIZATION HAD OCCURRED NATURALLY, AND WAS NOT RELATED TO THE COILS OR THE EMBOLIZATION PROCEDURE. THE DEVICE WAS IMPLANTED AND THUS NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. ANEURYSM RE-GROWTH AND SUBSEQUENT SYMPTOMS AFTER COIL EMBOLIZATION ARE KNOWN EVENTS. FACTORS WHICH MAY HAVE A CORRELATION WITH RE-GROWTH POST COIL EMBOLIZATION INCLUDE ANEURYSM CHARACTERISTICS/SIZE, NECK SIZE, INITIAL COIL PACKING DENSITY, AND INFLOW ANGLE. WITH REVIEW OF THE AVAILABLE PROCEDURAL INFORMATION AND DEVICE HISTORY REVIEW, IT APPEARS THAT PATIENT/CLINICAL FACTORS LIKELY CONTRIBUTED TO THE REPORTED EVENTS WITH NO INDICATION OF ANY MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS 1 OF 9 MDRS RELATED TO THIS COMPLAINT WITH ASSOCIATED MANUFACTURE REPORT NUMBERS: 1226348-2014-00145, 1226348-2014-00146, 1226348-2014-00147, 1226348-2014-00148, 1226348-2014-00149, 1226348-2014-00150, 1226348-2014-30045, 1226348-2014-30046 AND 1226348-2014-30047.

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA THE (B)(4) STUDY, APPROXIMATELY 3 YEARS AFTER AN (B)(6) FEMALE PATIENT WITH HA HISTORY OF CARDIOVASCULAR DISEASE AND PREVIOUS COIL EMBOLIZATION TO THE LEFT INTERNAL CAROTID ARTERY UNDERWENT STENT ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED LEFT PARASELLAR ANEURYSM WITH AN ENTERPRISE VRD (ENC452212/014224292) AND PRESIDIO 5MMX17CM (PC4100517-30/F62853), CASHMERE 4MMX8CM (CRC140408-30/G12500) X 2, CASHMERE 5MMX12CM (CRC140512-30/G12444), CASHMERE 4MMX6CM (CRC140406-30/G11782), CACHMERE 4MMX6CM (CRC140406-30/G12282), GALAXY 4MMX8MM (640CX0408/13500145), GALAXY 3.5MMX7.5MM (640CX3575/13500179), GALAXY 3.5MMX7.5MM (640CX3575/13500245), AND V-TRACK MICROPLEX X 4, DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED ANEURYSM RECANALIZATION DUE TO COIL COMPACTION. PRE-INDEX PROCEDURE OCCLUSION RATE WAS 50%, PARENT VESSEL WAS 4.3MM PROXIMAL AND 3.5MM DISTAL, NECK TO SAC RATIO WAS 5.5MM:15.1MM (MAXIMUM DIAMETER 15.5MM). POST-PROCEDURE OCCLUSION RATE WAS 96%, PARENT VESSEL WAS 4.1MM PROXIMAL AND 3.5MM DISTAL AND NECK TO SAC RATIO WAS UNCHANGED. ONE YEAR AFTER THE INDEX PROCEDURE, THE OCCLUSION RATE WAS 90%, VESSEL WAS 4.6MM PROXIMAL AND 3.7MM DISTAL, AND NECK TO SAC RATION WAS 5.7MM;15.1MM (MAXIMUM DIAMETER 15.5MM). THREE YEARS AFTER THE INDEX PROCEDURE, WHEN THE COIL COMPACTION AND RECANALIZATION WERE DIAGNOSED, THE OCCLUSION RATE WAS 70%, VESSEL WAS 4.1MM PROXIMAL AND 3.6MM DISTAL, NECK TO SAC RATIO WAS 6.5MM;19.4MM (MAXIMUM DIAMETER 20.0MM). THEREFORE, REPEAT COIL EMBOLIZATION, ASSISTED WITH ENTERPRISE VRD (ENC452212/014224292), WAS RE-CONDUCTED APPROXIMATELY ONE MONTH LATER. THE PROCEDURE WAS SUCCESSFUL WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCTS USED DURING THE INDEX PROCEDURE WERE NEW AND WERE STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. THE ENTERPRISE HAD BEEN FULLY EXPANDED WITH GOOD WALL APPOSITION, AND IT WAS REPORTED THAT THE VRD WAS SUCCESSFULLY RETAINING THE COILS INSIDE THE TARGET ANEURYSM AT THE TIME OF THE COIL COMPACTION. THE DEVICE WAS IMPLANTED AND THUS NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. ANEURYSM RE-GROWTH AND SUBSEQUENT SYMPTOMS AFTER COIL EMBOLIZATION ARE KNOWN EVENTS. FACTORS WHICH MAY HAVE A CORRELATION WITH RE-GROWTH POST COIL EMBOLIZATION INCLUDE ANEURYSM CHARACTERISTICS/SIZE, NECK SIZE, INITIAL COIL PACKING DENSITY, AND INFLOW ANGLE. WITH REVIEW OF THE AVAILABLE PROCEDURAL INFORMATION AND DEVICE HISTORY REVIEW, IT APPEARS THAT PATIENT/CLINICAL FACTORS LIKELY CONTRIBUTED TO THE REPORTED EVENTS WITH NO INDICATION OF ANY MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS 1 OF 9 MDR'S RELATED TO THIS COMPLAINT WITH ASSOCIATED MANUFACTURE REPORT NUMBERS: 1226348-2014-00145, 1226348-2014-00146, 1226348-2014-00147, 1226348-2014-00148, 1226348-2014-00149, 1226348-2014-00150, 1226348-2014-30045, 1226348-2014-30046 AND 1226348-2014-30047.

    Additional Manufacturer Narrative · 1

    (B)(4): CONCOMITANT DEVICES USED DURING THE PROCEDURE INCLUDED: ENTERPRISE VRD (ENC452212/014224292), CASHMERE 4MMX8CM (CRC140408-30/G12500) X 2, CASHMERE 5MMX12CM (CRC140512-30/G12444), CASHMERE 4MMX6CM (CRC140406-30/G11782), CACHMERE 4MMX6CM (CRC140406-30/G12282), GALAXY 4MMX8MM (640CX0408/13500145), GALAXY 3.5MMX7.5MM (640CX3575/13500179), GALAXY 3.5MMX7.5MM (640CX3575/13500245), AND V-TRACK MICROPLEX X 4.CONCOMITANT MEDICATIONS: WARFARIN 4MG 2008, ONGOING, PLAVIX 75MG (B)(6) 22011 THROUGH (B)(6) 2011, PLAVIX 50MG (B)(6) 2011, ONGOING,BAYSPIRIN 100MG (B)(6) 2011 THROUGH (B)(6) 2011,PLETAAL 100MG (B)(6) 2011, ONGOING.HEPARIN ON (B)(6) 2011.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(6), APPROXIMATELY 3 YEARS AFTER STENT ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED LEFT PARASELLAR ANEURYSM WITH AN ENTERPRISE VRD (ENC452212/014224292) AND PRESIDIO 5MMX17CM (PC4100517-30/F62853), CASHMERE 4MMX8CM (CRC140408-30/G12500) X 2, CASHMERE 5MMX12CM (CRC140512-30/G12444), CASHMERE 4MMX6CM (CRC140406-30/G11782), CACHMERE 4MMX6CM (CRC140406-30/G12282), GALAXY 4MMX8MM (640CX0408/13500145), GALAXY 3.5MMX7.5MM (640CX3575/13500179), GALAXY 3.5MMX7.5MM (640CX3575/13500245), AND V-TRACK MICROPLEX X 4, DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED ANEURYSM RECANALIZATION DUE TO COIL COMPACTION. PRE-INDEX PROCEDURE OCCLUSION RATE WAS 50%, PARENT VESSEL WAS 4.3MM PROXIMAL AND 3.5MM DISTAL, NECK TO SAC RATIO WAS 5.5MM:15.1MM (MAXIMUM DIAMETER 15.5MM). POST-PROCEDURE OCCLUSION RATE WAS 96%, PARENT VESSEL WAS 4.1MM PROXIMAL AND 3.5MM DISTAL AND NECK TO SAC RATIO WAS UNCHANGED. ONE YEAR AFTER THE INDEX PROCEDURE, THE OCCLUSION RATE WAS 90%, VESSEL WAS 4.6MM PROXIMAL AND 3.7MM DISTAL, AND NECK TO SAC RATION WAS 5.7MM;15.1MM (MAXIMUM DIAMETER 15.5MM). THREE YEARS AFTER THE INDEX PROCEDURE, WHEN THE COIL COMPACTION AND RECANALIZATION WERE DIAGNOSED, THE OCCLUSION RATE WAS 70%, VESSEL WAS 4.1MM PROXIMAL AND 3.6MM DISTAL, NECK TO SAC RATIO WAS 6.5MM;19.4MM (MAXIMUM DIAMETER 20.0MM). THEREFORE, REPEAT COIL EMBOLIZATION, ASSISTED WITH ENTERPRISE VRD (ENC452212/014224292), WAS RE-CONDUCTED APPROXIMATELY ONE MONTH LATER. THE PROCEDURE WAS SUCCESSFUL WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCTS USED DURING THE INDEX PROCEDURE WERE NEW AND WERE STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. THE ENTERPRISE HAD BEEN FULLY EXPANDED WITH GOOD WALL APPOSITION AND IT WAS REPORTED THAT THE VRD WAS SUCCESSFULLY RETAINING THE COILS INSIDE THE TARGET ANEURYSM AT THE TIME OF THE COIL COMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413652 XTRASOFT ORBIT GALAXY DETACHABLE COIL ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA 13500145

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention