BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY G3 XSFT 3MM X 6CM

    MDR report key: 16187143 · Received January 17, 2023

    Report

    Report Number
    3008114965-2023-00048
    Event Type
    Injury
    Date Received
    January 17, 2023
    Date of Event
    November 22, 2022
    Report Date
    May 21, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077695
    PMA / PMN Number
    K150319
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). PROCODE: KRD/HCG. THE DEVICE REMAINS IMPLANTED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30603573 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. COIL COMPACTION MAY LEAD TO THE RETURN OF BLOOD FLOW INTO THE ANEURYSM AND MAY INCREASE THE RISK FOR ANEURYSM RUPTURE AND POSSIBLY REQUIRE ADDITIONAL INTERVENTION. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 ASIDE FROM ¿ANEURYSM INCREASE IN SIZE¿, THE OTHER REASON FOR RETREATMENT WAS ¿COIL COMPACTION¿, BUT IT¿S NOT SPECIFIED WHICH COIL WAS COMPACTED. THEREFORE, SINCE THE RELATIONSHIP BETWEEN THE RESIDUAL ANEURYSM AND THE CERENOVUS STUDY COILS CANNOT BE EXCLUDED, THIS EVENT DOES MEET MDR REPORTING CRITERIA AS A ¿SERIOUS INJURY. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2023-00045, 3008114965-2023-00046, 3008114965-2023-00047 AND 3008114965-2023-00048. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, B5, G3, G6, H2 AND H11. SECTION B5: ADDITIONAL/MODIFIED INFORMATION WAS RECEIVED ON 13-MAY-2025. SUMMARY: DESCRIPTION OF DEVICE DEFICIENCY WAS UPDATED FROM "ROUTINE IMAGING ON (B)(6) 2022 SHOWED RECANALIZATION OF THE NECK AND BODY WITH PROTECTION OF THE DOME OF THE ANEURYSM. THE CAUSE OF RECANALIZATION WAS BOTH COIL COMPACTION AND RE-GROWTH OF ANEURYSM" TO "ROUTINE IMAGING ON (B)(6) 2022 SHOWED RECANALIZATION OF THE NECK AND BODY WITH PROTECTION OF THE DOME OF THE ANEURYSM. THE CAUSE OF RECANALIZATION WAS RE-GROWTH OF ANEURYSM." A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    AS REPORTED BY THE STERLING STUDY, A 54-YEAR-OLD FEMALE (SUBJECT (B)(6) WITH NO TARGETED MEDICAL HISTORY UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CEREBRAL ARTERY ANEURYSM ON (B)(6) 2022. THE PATIENT¿S BASELINE MODIFIED RANKIN SCALE SCORE WAS 0 AND THE HUNT & HESS GRADE WAS 2 - MODERATE TO SEVERE HEADACHE, NUCHAL RIGIDITY, AND NO NEUROLOGIC DEFICIT OTHER THAN CRANIAL NERVE PALSY. THE DIMENSIONS OF THE ANTERIOR CEREBRAL ARTERY ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT OF 8.5 MM, DOME 8.1 MM, MAXIMUM ANEURYSM DIAMETER OF 8.1 MM, NECK SIZE OF 2.6 MM, AND THE DOME-TO-NECK RATIO OF 3.1 MM. THE PARENT VESSEL DIAMETER WAS 1.7 MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH FOUR (4) CERENOVUS COILS VIA AN SL-10 MICROCATHETER (STRYKER). THE COILS WERE THE FOLLOWING: ONE 8MM X 13.6MM MICRUSFRAME S (MFR180813/K10699), ONE 6 MM X 15 CM GALAXY G3 (GLY120615/K10390), ONE 4 MM X 12 CM GALAXY G3 (GLY120412/30637578), AND ONE GALAXY G3 XTRASOFT (GLX120306/30603573). HEPARIN WAS ADMINISTERED. THE SUBJECT DID NOT EXPERIENCE INTRA-OPERATIVE RUPTURE OR THROMBOEMBOLIC EVENTS. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS II: RESIDUAL NECK = PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL BUT WITHOUT OPACIFICATION OF THE ANEURYSMAL SAC. THERE WERE NO REPORTED STUDY DEVICE DEFICIENCIES. ON (B)(6) 2022 THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER WITH A MODIFIED RANKIN SCALE SCORE OF 1. ON (B)(6) 2022 THE PATIENT UNDERWENT RETREATMENT OF TARGET ANEURYSM USING A FLOW DIVERTER DUE TO AN INCREASE IN ANEURYSM SIZE. THE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE FOLLOWING RETREATMENT WAS CLASS I: COMPLETE = COMPLETE OBLITERATION. THE SUBJECT DID NOT EXPERIENCE INTRA-OPERATIVE ANEURYSM RUPTURE OR THROMBOEMBOLIC EVENTS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 WAS REVIEWED. SUMMARY OF THE INFORMATION PROVIDED: THE REASON FOR THE RETREATMENT OF THE TARGET ANEURYSM WAS UPDATED TO INCLUDE ¿COIL COMPACTION¿. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 WAS REVIEWED. SUMMARY OF THE INFORMATION PROVIDED: THE DEVICE DEFICIENCY LOG WAS UPDATED ON THE CASE REPORT FORMS (CRF) INDICATING THAT THERE WAS COIL COMPACTION WITH ALL THE INVOLVED COILS. ROUTINE IMAGING ON (B)(6) 2022 SHOWED RECANALIZATION OF THE NECK AND BODY WITH THE PROTECTION OF THE DOME OF THE ANEURYSM. THE CAUSE OF RECANALIZATION WAS BOTH COIL COMPACTION AND THE RE-GROWTH OF THE ANEURYSM. THE COILS DID REMAIN WITHIN THE ANEURYSM SAC. THE PATIENT WAS NOT SYMPTOMATIC AS A RESULT OF RECANALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656769 GALAXY G3 XSFT 3MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLX120306 30603573 10886704077695

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention GALAXY G3 4MM X 12CM| GALAXY G3 6MM X 15CM| MICRUSFRAME18 8MM X 13.6CM