BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY G3 XSFT 3MM X 4CM

    MDR report key: 13667932 · Received March 4, 2022

    Report

    Report Number
    3008114965-2022-00168
    Event Type
    Injury
    Date Received
    March 4, 2022
    Date of Event
    August 6, 2013
    Report Date
    March 4, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077688
    PMA / PMN Number
    K150319
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: DING D, LIU KC. MANAGEMENT STRATEGIES FOR INTRAPROCEDURAL COIL MIGRATION DURING ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS. J NEUROINTERV SURG. 2014 JUL;6(6):428-31. DOI: 10.1136/NEURINTSURG-2013-010872. EPUB 2013 AUG 6. PMID: 23921713. THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE INITIAL REPORTER PHONE IS NOT AVAILABLE. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE (S) WERE NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBERS PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. SINCE THE ALLEGED COIL MIGRATION RESULTED IN CEREBRAL THROMBOSIS WITH THE NEED FOR MEDICAL AND SURGICAL INTERVENTION TO PRECLUDE FURTHER DAMAGE, THE EVENT IS CONSIDERED SERIOUS AND MDR REPORTABLE. THERE IS NO INDICATION OF A DEVICE DESIGN OR MANUFACTURING ISSUE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: DING D, LIU KC. MANAGEMENT STRATEGIES FOR INTRAPROCEDURAL COIL MIGRATION DURING ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS. J NEUROINTERV SURG. 2014 JUL;6(6):428-31. DOI: 10.1136/NEURINTSURG-2013-010872. EPUB 2013 AUG 6. PMID: 23921713. OBJECTIVE AND METHODS: THIS ARTICLE PRESENTS A PARTICULAR MANAGEMENT STRATEGY FOR CORRECTION OF A DISTAL COIL MIGRATION IN A PATIENT UNDERGOING ENDOVASCULAR COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 3MM X 4CM GALAXY G3 XSFT COIL & PROWLER 10 MICROCATHETER. CONCOMITANT CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: GALAXY G3 XSFT COILS; GALAXY G3 MINI COILS. CONCOMITANT NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: 6F CHAPERON GUIDING CATHETER (MICROVENTION); 0.014" TRANSEND MICROWIRE (BOSTON SCIENTIFIC); 3/30 MM ATLAS 2 STENT (STRYKER) . ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: A (B)(6) MALE PATIENT UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM. A PROWLER 10 MICROCATHETER WAS CAREFULLY ADVANCED OVER A 0.014 TRANSEND MICROWIRE (BOSTON SCIENTIFIC) AND POSITIONED INTO THE ANEURYSM SAC. ONE 4/8 MM GALAXY G3 XSFT COIL WAS THEN INSERTED AND DETACHED INTO ANEURYSM. AT THE BEGINNING OF THE INTRODUCTION OF THE SECOND COIL 3/4, THE TIP OF THE MICROCATHETER DESCENDED TO THE ANEURYSM NECK. AS SOON AS IT WAS DETACHED, THE FLOW CARRIED A PART OF THE COIL FROM THE ANEURYSM TO A2 SEGMENT OF THE RIGHT ANTERIOR CEREBRAL ARTERY. THE NEXT CONTRAST INJECTION DEMONSTRATED THROMBOSIS OF THE RIGHT A2 WITHOUT FLOW DISTAL TO THE MIGRATED COIL. THE RIGHT A2 WAS THEN CATHETERIZED THROUGH THE LEFT A1 WITH AN EXCELSIOR 10 MICROCATHETER. THE MICROCATHETER WAS ADVANCED PROXIMAL TO THE MIGRATED COIL, AND 5 ML HEPARIN SOLUTION WAS INFUSED. THE MICROCATHETER WAS PASSED CAREFULLY DISTAL TO THE COIL, AND A 3/30 MM ATLAS 2 STENT (STRYKER) WAS DEPLOYED AND SUCCESSFULLY FIXED AND STABILIZED THE MIGRATED COIL. IMAGING DEMONSTRATED GOOD REPERMEABILIZATION OF THE RIGHT A2 SEGMENT. ANGIOGRAPHIC OCCLUSION OF THE ANEURYSM WAS OBTAINED AFTER THE SAFE INSERTION AND DETACHMENT OF OTHER TWO COILS (2/ 8 MM GALAXY G3 XSFT AND 1.5/ 4 MM GALAXY G3 MINI). A CEREBRAL COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED 7 DAYS POSTOPERATIVELY AND SHOWED THE TOTAL SUBARACHNOID HEMORRHAGE (SAH) RESORPTION. THE PATIENT WAS DISCHARGED HOME AFTER 17 DAYS OF HOSPITALIZATION IN GOOD NEUROLOGICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569849 GALAXY G3 XSFT 3MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLX120304 10886704077688

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention 0.014" TRANSEND MICROWIRE (BOSTON SCIENTIFIC)| 3/30 MM ATLAS 2 STENT (STRYKER)| 6F CHAPERON GUIDING CATHETER (MICROVENTION)| GALAXY G3 MINI COILS| GALAXY G3 XSFT COILS