BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBIT GALAXY DETACHABLE COIL SYSTEM

    MDR report key: 3250108 · Received July 26, 2013

    Report

    Report Number
    1226348-2013-10041
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    November 9, 2012
    Report Date
    July 4, 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

    FOR THE FIRST ANEURYSM (A) BALLOON WAS USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED DUE TO SATISFACTORY RESULTS. NO TECHNICAL ADVERSE EVENT OR SUB-ARACHNOIDS HEMORRHAGE WERE REPORTED DURING THE PROCEDURE. THE FINAL ANGIOGRAPHIC RESULT INDICATED THAT THERE WAS COMPLETE OCCLUSION. FOR THE SECOND ANEURYSM (B) NO ADDITIONAL TECHNIQUE WAS USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED DUE TO SATISFACTORY RESULTS. NO TECHNICAL ADVERSE EVENT OR SUB-ARACHNOIDS HEMORRHAGE WERE REPORTED DURING THE PROCEDURE. THE FINAL ANGIOGRAPHIC RESULT INDICATED THAT THERE WAS COMPLETE OCCLUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. ON (B)(6) 2012, THERE WAS A SUDDEN OCCURRENCE ON THE LEFT TRIGEMIAL NERVE DEFICIT LESS THAN 24H (HYPOESTHESIA WITHOUT MOTOR NERVE DEFICIT). EXAMS PERFORMED: MRI, CORONAROGRAPHY, CT-SCAN. EVOLUTION : COMPRESSION SYNDROME BY COILS LOCATED NEAR FROM THE NERVE. THIS IS RESPONSIBLE FOR THE SYMPTOMS OF NERVE DEFICIT. IN CASE OF EVOLUTION, A DECOMPRESSIVE INTERVENTION OF THE NERVE COULD BE CONSIDERED. ADVERSE EVENT WAS RESOLVED ON THE 2013, (B)(6) BUT THE PATIENT IS STILL EXPERIENCING A LITTLE HYPOESTHESIA ON HER CHEEK. THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ORBIT GALAXY HELICAL XTRASOFT COIL 2 X 8 (640HX0208/LOT UNKNOWN).

    Additional Manufacturer Narrative · 1

    VIA THE TRULINE STUDY AN ADVERSE EVENT OF SUDDEN LEFT TRIGEMINAL NERVE DEFICIT DUE TO COMPRESSION SYNDROME BY THE COILS LOCATED NEAR THE NERVE WAS REPORTED AS OCCURRING APPROXIMATELY ELEVEN WEEKS AFTER ENDOVASCULAR TREATMENT OF AN ACUTELY RUPTURED LEFT POSTERIOR COMMUNICATING (PCOM) AND NON-RUPTURED LEFT VERTEBRAL ARTERY (VA) ANEURYSM. THERE WERE NO PROCEDURAL COMPLICATIONS OR TECHNICAL ADVERSE EVENTS WITH IMPLANTATION OF A 2X8 GALAXY HELICAL XTRASOFT (640HX0208/15566182), TWO 2X2 GALAXY COMPLEX XTRASOFT (640CX0202/15351217) AND TWO NONCODMAN NEUROVASC. HELICAL ULTRA (2X2 & 2X1) COILS. THE EVENT WAS REPORTED AS RESOLVED TWO MONTHS LATER; HOWEVER THE PATIENT IS STILL EXPERIENCING A LITTLE HYPOESTHESIA ON HER CHEEK. AT BASELINE THE PATIENT WAS ADMITTED WITH AN ACUTELY RUPTURED LEFT PCOM. THE ANEURYSM HAD A SAC HEIGHT 3.0 MM, SAC WIDTH UNKNOWN AND NECK UNKNOWN. THE NON-RUPTURED ANEURYSM ON LEFT VA HAD A SAC HEIGHT 2.0 MM, SAC WIDTH UNKNOWN AND NECK UNKNOWN WHICH WERE DISCOVERED FOLLOWING SYMPTOMS RELATED TO SAH. THE PATIENT HAD NO HISTORY OF PREVIOUS SAH, ENDOVASCULAR OR SURGERY TREATMENT FROM ANOTHER ANEURYSM. AT BASELINE, THE MRS WAS 0. PATIENT MEDICAL HISTORY: CURRENT SMOKER, NO DIABETES, NO HYPERLIPIDEMIA, NO HYPERTENSION. AT INDEX PROCEDURE A BALLOON WAS USED FOR TREATMENT OF THE PCOM ANEURYSM. THE PROCEDURE WAS COMPLETED DUE TO SATISFACTORY RESULTS. NO TECHNICAL ADVERSE EVENT OR SUB-ARACHNOIDS HEMORRHAGE WERE REPORTED DURING THE PROCEDURE. THE FINAL ANGIOGRAPHIC RESULT INDICATED THAT THERE WAS COMPLETE OCCLUSION. THERE WAS NO ADDITIONAL TECHNIQUE USED DURING THE TREATMENT OF THE VA ANEURYSM. THE PROCEDURE WAS COMPLETED DUE TO SATISFACTORY RESULTS. NO TECHNICAL ADVERSE EVENT OR SUB-ARACHNOIDS HEMORRHAGE WERE REPORTED DURING THE PROCEDURE. THE FINAL ANGIOGRAPHIC RESULT INDICATED THAT THERE WAS COMPLETE OCCLUSION. THE PATIENT WAS DISCHARGED EIGHT DAYS POST PROCEDURE. ELEVEN MONTHS POST PROCEDURE THERE WAS SUDDEN OCCURRENCE OF THE LEFT TRIGEMINAL NERVE DEFICIT LESS THAN 24 HOURS WITH HYPOESTHESIA WITHOUT MOTOR NERVE DEFICIT. MRI, CORONAROGRAPHY, CT-SCAN WERE PERFORMED WITH REPORT OF COMPRESSION SYNDROME BY COILS LOCATED NEAR FROM THE NERVE. THIS IS RESPONSIBLE FOR THE SYMPTOMS OF NERVE DEFICIT. IN CASE OF EVOLUTION, A DECOMPRESSIVE INTERVENTION OF THE NERVE COULD BE CONSIDERED. THE COILS REMAIN IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH GALAXY LOTS 15566182 AND 15351217 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. NEUROLOGICAL DEFICITS AND INJURY TO NORMAL TISSUE ARE KNOWN POTENTIAL COMPLICATIONS SPECIFIC TO EMBOLIZATION PROCEDURES THAT CAN OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. COMPRESSION OF BRAIN STRUCTURES/CRANIAL NERVES IS A KNOWN FACTOR CONTRIBUTING TO NEUROLOGICAL SYMPTOMS. ALTHOUGH NO CONCLUSION CAN BE MADE BASED ON THE AVAILABLE INFORMATION, PROCEDURAL FACTORS AND CLINICAL FACTORS APPEAR TO HAVE CONTRIBUTED TO THE REPORTED. THERE IS NO INDICATION OF ANY DEVICE DESIGN OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    COMPRESSION SYNDROME BY COILS LOCATED NEAR FROM THE NERVE. ADVERSE EVENT WAS RESOLVED ON THE 2013, (B)(6) BUT THE PATIENT IS STILL WITH SYMPTOMS. PATIENT WAS ADMITTED WITH AN ACUTELY RUPTURED ANEURYSM ON LEFT POSTERIOR COMMUNICATING (ANEURYSM A) (SAC HEIGHT 3.0 MM, SAC WIDTH UNKNOWN AND NECK UNKNOWN), AND A NON-RUPTURED ANEURYSM ON LEFT VERTEBRAL ARTERY (ANEURYSM B) (SAC HEIGHT 2.0 MM, SAC WIDTH UNKNOWN AND NECK UNKNOWN) DISCOVERED FOLLOWING SYMPTOMS RELATED TO SAH. THE PATIENT HAD NO HISTORY OF PREVIOUS SAH, ENDOVASCULAR OR SURGERY TREATMENT FROM ANOTHER ANEURYSM. AT BASELINE, THE MRS WAS 0. PATIENT MEDICAL HISTORY: CURRENT SMOKER, NO DIABETES, NO HYPERLIPIDEMIA, NO HYPERTENSION DURING THE INDEX PROCEDURE 4 COILS WERE IMPLANTED IN ANEURYSM ON (B)(6) 2012: 1 COIL TRUFILL GALAXY: 640HX0208/15566182 - GALAXY HELICAL XTRASOFT 2MMX8CM; 2 COILS TRUFILL GALAXY: 640CX0202/15351217 - GALAXY COMPLEX XSTRASOFT 02MMX02CM (LOT# ); 1 NEUROVASC. HELICAL ULTRA 2MMX2CM; 1 NEUROVASC. HELICAL ULTRA 2MMX1CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350673 ORBIT GALAXY DETACHABLE COIL SYSTEM ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA 15351217

    Patients

    Seq Age Sex Outcome Treatment
    1