BEUDAMED
    FDA Adverse Event Summary report: N

    XTRASOFT ORBIT GALAXY DETACHABLE COIL

    MDR report key: 5012724 · Received August 19, 2015

    Report

    Report Number
    3008264254-2015-00057
    Date Received
    August 19, 2015
    Date of Event
    May 2, 2013
    Report Date
    October 16, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WILL BE FORTHCOMING FOR THIS REPORT.

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: AT THE ONE YEAR FOLLOW UP, THE PATIENT REMAINED SYMPTOM FREE. ANGIOGRAPHY WAS PERFORMED THAT REVEALED THERE WAS RESIDUAL NECK FILLING AND OCCLUSION WAS 90-99%; HOWEVER, COMPARISON TO THE INDEX PROCEDURE FILMS SHOWED THE ANEURYSM TO BE WORSE WITH RECANALIZATION, CLASSIFIED AS MINOR. THERE IS NO REPORT OF TREATMENT OF RECANALIZATION. FURTHER FOLLOW-UP SHOWED A RECANALIZATION, FOR WHICH A SECOND EMBOLIZATION WAS SUCCESSFULLY PERFORMED ON NINETEEN MONTHS AFTER THE INDEX PROCEDURE. THE TARGET ANEURYSM WAS LOCATED AT ACA (ANTERIOR COMMUNICATING ARTERY), WAS NON-RUPTURED, SAC SIZE OF 7.8MM WITH A NECK OF 4.7MM. THIS PATIENT PRESENTED WITH NO SYMPTOMS. PAST MEDICAL HISTORY INCLUDES CURRENT SMOKER, HYPERTENSION AND A NEGATIVE FAMILY HISTORY FOR ANEURYSM. THE ORBIT WITH LOT 15757695 WAS NOT RETURNED; THEREFORE THE ROOT CAUSE OF THE EVENTS CANNOT BE DETERMINED. 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. SUBARACHNOID HEMORRHAGE, RUPTURED ANEURYSM AND RECANALIZATION OF THE ANEURYSM ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE COILS AS OUTLINED IN THE INSTRUCTIONS FOR USE. CLINICAL AND PROCEDURAL FACTORS 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. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THIS TRULINE STUDY FOR PATIENT WITH ID 1-80 HAD SUBARACHNOID HEMORRHAGE DURING THE INDEX PROCEDURE WHEN THE THIRD ORBIT GALAXY 5 MM X 15 CM (15763742) WAS IMPLANTED, AND AT THE ONE YEAR FOLLOW-UP, ANGIOGRAPHY WAS PERFORMED THAT REVEALED REALIZATION. DURING THE INDEX PROCEDURE, WHILE POSITIONING THE 3RD COIL, A SLIGHT PRESSURE WAS APPLIED AND THE HEMORRHAGE OCCURRED. ADDITIONALLY, IT WAS NOTED THAT MAYBE THE PRESENCE OF THE BALLOON CONTRIBUTED SOMEWHAT AS IT MAY HAVE LIMITED THE MOVEMENT OF THE MICROCATHETER INTO THE SAC. NO OTHER DEVICES CONTRIBUTE TO THE EVENT. ALSO, MINOR RECANALIZATION WAS REPORTED POST INDEX PROCEDURE. THE PHYSICIAN INDICATED ONLY THE THIRD COIL CAUSED THE SUBARACHNOID HEMORRHAGE. DURING THE INDEX PROCEDURE, A SINGLE ANEURYSM WAS TREATED WITH TEN CODMAN COILS (640CF0515/15763742 - GALAXY COMPLEX FILL 5MMX15CM 41; 640CX3509 /15763742; 640CX3505 / 15571266; 640CX2505/15761907; 640CX2535/15710778; 640CX02525/15761909; 640CX0202/15710778, 640CX02525/15757695, 640CF0620/15761620, & PC410073030/(B)(4)) WERE IMPLANTED USING AN OCCLUSION BALLOON ASSISTED TECHNIQUE. NON-CODMAN GUIDE, MICROCATHETER, WIRE AND BALLOON WERE USED. SATISFACTORY RESULTS WERE OBTAINED, THERE WAS RESIDUAL NECK; HOWEVER, THE SAC OCCLUSION WAS 90-99%. DURING THE INDEX PROCEDURE, THE ORDER OF COIL IMPLANTATION CONSISTED OF FIRST PRESIDIO 10 CERECYTE COIL 7MM X 30 CM, SECOND ORBIT GALAXY 6 MM X 20 CM, AND THIRD ORBIT GALAXY 5 MM X 15 CM, AND THE REASON WHY THE ANEURYSM WAS LEFT WITH 90-99% INSTEAD OF 100% THAT THERE WAS A RESIDUAL FILLING AT THE NECK, WHEREAS THE SAC WAS COMPLETELY EXCLUDED, AND THE PHYSICIAN WAS AFRAID OF A POSSIBLE CLOT FORMATION AFTER THE HEMORRHAGE. CLINICAL EVOLUTION WAS FAVORABLE, AND THE PATIENT QUIT THE HOSPITAL ON DAY 5 WITHOUT ANY DEFICIT OR HEADACHES. AT THE 30 DAY FOLLOW UP VISIT, THE PATIENT HAD NO SYMPTOMS AND NO REPORT OF ADVERSE EVENT. AT THE ONE YEAR FOLLOW UP, THE PATIENT REMAINED SYMPTOM FREE. ANGIOGRAPHY WAS PERFORMED THAT REVEALED THERE WAS RESIDUAL NECK FILLING AND OCCLUSION WAS 90-99%; HOWEVER, COMPARISON TO THE INDEX PROCEDURE FILMS SHOWED THE ANEURYSM TO BE WORSE WITH RECANALIZATION, CLASSIFIED AS MINOR. THERE IS NO REPORT OF TREATMENT OF RECANALIZATION. FURTHER FOLLOW-UP SHOWED A RECANALIZATION, FOR WHICH A SECOND EMBOLIZATION WAS SUCCESSFULLY PERFORMED ON NINETEEN MONTHS AFTER THE INDEX PROCEDURE. THE TARGET ANEURYSM WAS LOCATED AT ACA (ANTERIOR COMMUNICATING ARTERY), WAS NON-RUPTURED, SAC SIZE OF 7.8MM WITH A NECK OF 4.7MM. THIS PATIENT PRESENTED WITH NO SYMPTOMS. PAST MEDICAL HISTORY INCLUDES CURRENT SMOKER, HYPERTENSION AND A NEGATIVE FAMILY HISTORY FOR ANEURYSM. THE PATIENT HAS A HISTORY OF DIABETES, SMOKER, HYPERTENSION TREATED WITH COVERSYL 2MG, AND HYPERLIPIDEMIA. THE PATIENT HAS A FAMILY HISTORY OF ANEURYSM. ANEURYSM HEIGHT WAS 7.80MM, NECK WAS 4.70MM, NON-RUPTURED, AND THE PATIENT HAD NOT SYMPTOMS. OTHER DEVICES USED CONSISTED OF 2 INTRODUCER, MICROCATHETER ECHELON 14, GUIDEWIRES TRANSEND 14, BALLOON 5 HYPERFORM 4X7MM AND BALLOON ECLIPSE 7MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS (B)(6) PATIENT HAD SUBARACHNOID HEMORRHAGE DURING THE INDEX PROCEDURE WHEN THE THIRD ORBIT GALAXY 5 MM X 15 CM (15763742) WAS IMPLANTED AND DURING THE POSITIONING OF THE 3RD COIL, A SLIGHT PRESSURE WAS APPLIED AND THE HEMORRHAGE OCCURRED. MAY BE THE PRESENCE OF THE BALLOON CONTRIBUTED SOMEWHAT AS IT MAY HAVE LIMITED THE MOVEMENT OF THE MICROCATHETER INTO THE SAC. NO OTHER DEVICES CONTRIBUTE TO THE EVENT. ALSO, MINOR RECANALIZATION WAS REPORTED POST INDEX PROCEDURE. THE PHYSICIAN INDICATED ONLY THE THIRD COIL CAUSED THE SUBARACHNOID HEMORRHAGE. DURING THE INDEX PROCEDURE, A SINGLE ANEURYSM WAS TREATED WITH TEN CODMAN COILS (640CF0515/15763742 - GALAXY COMPLEX FILL 5MMX15CM 41; 640CX3509 /15763742; 640CX3505 / 15571266; 640CX2505/15761907; 640CX2535/15710778; 640CX02525/15761909; 640CX0202/15710778, 640CX02525/15757695, 640CF0620/15761620, & PC410073030/C1260) WERE IMPLANTED USING AN OCCLUSION BALLOON ASSISTED TECHNIQUE. NON-CODMAN GUIDE, MICROCATHETER, WIRE AND BALLOON WERE USED. SATISFACTORY RESULTS WERE OBTAINED, THERE WAS RESIDUAL NECK; HOWEVER, THE SAC OCCLUSION WAS 90-99%. DURING THE INDEX PROCEDURE, THE ORDER OF COIL IMPLANTATION CONSISTED OF FIRST PRESIDIO 10 CERECYTE COIL 7MM X 30 CM, SECOND ORBIT GALAXY 6 MM X 20 CM, AND THIRD ORBIT GALAXY 5 MM X 15 CM, AND THE REASON WHY THE ANEURYSM WAS LEFT WITH 90-99% INSTEAD OF 100% THAT THERE WAS A RESIDUAL FILLING AT THE NECK, WHEREAS THE SAC WAS COMPLETELY EXCLUDED, AND THE PHYSICIAN WAS AFRAID OF A POSSIBLE CLOT FORMATION AFTER THE HEMORRHAGE. CLINICAL EVOLUTION WAS FAVORABLE, AND THE PATIENT QUIT THE HOSPITAL ON DAY 5 WITHOUT ANY DEFICIT OR HEADACHES. AT THE 30 DAY FOLLOW UP VISIT, THE PATIENT HAD NO SYMPTOMS AND NO REPORT OF ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547802 XTRASOFT ORBIT GALAXY DETACHABLE COIL ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC 15757695

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening