BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBIT GALAXY DETACHABLE COIL SYSTEM

    MDR report key: 3169217 · Received June 14, 2013

    Report

    Report Number
    1226348-2013-10029
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    December 7, 2012
    Report Date
    May 15, 2013
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS REPORT IS FOR THE FOLLOWING PRODUCTS AND ALSO REPRESENT THE PRODUCT NOTED: 1 COIL TRUFILL GALAXY 640CX0410 - GALAXY COMPLEX XTRASOFT 4MMX10CM (15690704); 1 COIL TRUFILL GALAXY 640CF0306 - GALAXY MINI COMPLEX 3MMX 6CM (15673904); 3 COIL TRUFILL GALAXY 640CX0202 - GALAXY COMPLEX XTRASOFT 2MMX2CM (15701050). BECAUSE IT IS UNKNOWN WHICH DEVICE IF ANY CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE (B)(6) STUDY FOR PATIENT WITH (B)(6) WAS ADMITTED WITH A NON RUPTURED ANEURYSM OF ANTERIOR COMMUNICATING ARTERY (SAC HEIGHT UK MM, SAC WIDTH UK MM AND NECK UK MM), DISCOVERED FOLLOWING SYMPTOMS RELATED TO SAH, AND DURING THE PROCEDURE WITH GALAXY COILS, A THROMBOTIC EVENT WAS REPORT. MEDICATIONS GIVEN DURING THE INTERVENTION CONSISTED OF REOPRO AND HEPARIN IV THERAPEUTIC, AND HEPARIN IV THERAPEUTIC DOSAGE DURING 48H AFTER EMBOLIZATION. THE CURRENT PATIENT CONDITION WAS INDICATED THAT THE EVENT WAS RESOLVED WITHOUT ANY NEUROLOGIC SEQUEALE. THE EVENT WAS NOT RELATED TO THE COIL, AND WAS RESOLVED WITHOUT SEQUEALE THE SAME DAY. THE PATIENT WAS DISCHARGED TWO WEEKS AFTER THE INDEX PROCEDURE. AT BASELINE, THE MRS WAS NO SIGNIFICANT DISABILITY DESPITE SYMPTOMS AND HUNT AND HESS SCORE, ASYMPTOMATIC, MILD, HEADACHE, SLIGHT NUCHAL RIGIDITY. THE PATIENT MEDICAL HISTORY CONSISTED OF NO HYPERTENSION, CURRENT SMOKER, NO DIABETES, AND NO HYPERLIPIDEMIA. DURING THE INDEX PROCEDURE 5 COILS WERE IMPLANTED AT THE DESIRED SITE: 1 COIL TRUFILL GALAXY 640CX0410 - GALAXY COMPLEX XTRASOFT 4MMX10CM (15690704); 1 COIL TRUFILL GALAXY 640CF0306 - GALAXY MINI COMPLEX 3MMX 6CM (15673904); 3 COIL TRUFILL GALAXY 640CX0202 - GALAXY COMPLEX XTRASOFT 2MMX2CM (15701050). NO ADDITIONAL TECHNIQUE WAS USED DURING THE PROCEDURE (BALLOON/STENT). THE PROCEDURE WAS COMPLETED DUE TO SATISFACTORY RESULTS. NO SUB-ARACHNOIDS HEMORRHAGE WAS REPORTED BEFORE THE PROCEDURE, WITHOUT MODIFICATION OF INITIAL PROCEDURE PLAN. THE FINAL ANGIOGRAPHIC RESULTS WAS SATISFACTORY. 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 LOTS (15701050, 15673904, & 15690704) REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THROMBOEMBOLISM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE COILS AS OUTLINED IN THE INSTRUCTIONS FOR USE. PHARMACOLOGICAL AND CLINICAL FACTORS INCLUDING THIS PATIENT¿S PRE-PROCEDURE PRESENTATION WITH AN ANEURYSM MAY HAVE CONTRIBUTED TO THE EVENT. BASED ON THE REPORTED INFORMATION, THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE (B)(4) STUDY FOR PATIENT WITH ID (B)(6) WAS ADMITTED WITH A NON RUPTURED ANEURYSM OF ANTERIOR COMMUNICATING ARTERY (SAC HEIGHT UK MM, SAC WIDTH UK MM AND NECK UK MM), DISCOVERED FOLLOWING SYMPTOMS RELATED TO SAH, AND DURING THE PROCEDURE WITH GALAXY COILS AND A THROMBOTIC EVENT WAS REPORT. MEDICATIONS GIVEN DURING THE INTERVENTION CONSISTED OF REOPRO AND HEPARIN IV THERAPEUTIC, AND HEPARIN IV THERAPEUTIC DOSAGE DURING 48H AFTER EMBOLIZATION. THE CURRENT PATIENT CONDITION WAS INDICATED THAT THE EVENT WAS RESOLVED WITHOUT ANY NEUROLOGIC SEQUEALE. THE EVENT WAS NOT RELATED TO THE COIL, AND WAS RESOLVED WITHOUT SEQUEALE THE SAME DAY. THE PATIENT WAS DISCHARGED TWO WEEKS AFTER THE INDEX PROCEDURE. AT BASELINE, THE MRS WAS NO SIGNIFICANT DISABILITY DESPITE SYMPTOMS AND HUNT AND HESS SCORE, ASYMPTOMATIC, MILD, HEADACHE, SLIGHT NUCHAL RIGIDITY. THE PATIENT MEDICAL HISTORY CONSISTED OF NO HYPERTENSION, CURRENT SMOKER, NO DIABETES, AND NO HYPERLIPIDEMIA. DURING THE INDEX PROCEDURE 5 COILS WERE IMPLANTED AT THE DESIRED SITE: - 1 COIL TRUFILL GALAXY 640CX0410 - GALAXY COMPLEX XTRASOFT 4MMX10CM (15690704) - 1 COIL TRUFILL GALAXY 640CF0306 - GALAXY MINI COMPLEX 3MMX 6CM (15673904) - 3 COIL TRUFILL GALAXY 640CX0202 - GALAXY COMPLEX XTRASOFT 2MMX2CM (15701050) NO ADDITIONAL TECHNIQUE WAS USED DURING THE PROCEDURE (BALLOON/STENT). THE PROCEDURE WAS COMPLETED DUE TO SATISFACTORY RESULTS. NO SUB-ARACHNOIDS HEMORRHAGE WAS REPORTED BEFORE THE PROCEDURE, WITHOUT MODIFICATION OF INITIAL PROCEDURE PLAN. THE FINAL ANGIOGRAPHIC RESULTS WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271380 ORBIT GALAXY DETACHABLE COIL SYSTEM ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention