BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY G3 XSFT 4MM X 10CM

    MDR report key: 15936859 · Received December 7, 2022

    Report

    Report Number
    3008114965-2022-00789
    Event Type
    Injury
    Date Received
    December 7, 2022
    Date of Event
    May 25, 2022
    Report Date
    March 28, 2023
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077718
    PMA / PMN Number
    K150319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT DATE OF BIRTH, AND WEIGHT WERE NOT PROVIDED. PROCODE IS KRD/HCG. [CONCLUSION]: THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 54-YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION AND BEING A CURRENT SMOKER, UNDERWENT COIL EMBOLIZATION OF A MIDLINE RUPTURED ANEURYSM IN THE BIFURCATION OF THE ANTERIOR COMMUNICATING ARTERY WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0 AND A HUNT & HESS GRADE OF 3 (DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT) ON 19-SEP-2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 8MM, DOME 6MM, MAXIMUM ANEURYSM DIAMETER 8MM, NECK SIZE 5MM, AND THE DOME-TO-NECK RATIO OF 1.2MM. THE PARENT VESSEL DIAMETER WAS 2.7MM. BASED ON THE MODIFIED INFORMATION RECEIVED ON (B)(6) 2022, COIL EMBOLIZATION WAS PERFORMED AND THE FOLLOWING COILS WERE IMPLANTED: AN 8MM X 16.1CM MICRUSFRAME 10 (MFR100816 / L15372), A 5MM X 15CM GALAXY G3 (GLY120515 / 30517632), A 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535 / K10121), A 6MM X 11.9CM MICRUSFRAME 10 (MFR100611 / L16158), A 5MM X 15CM GALAXY G3 (GLY120515 / K10721), A 4MM X 10CM GALAXY G3 XSFT (GLX120410 / K10380), AND A 3MM X 8CM GALAXY G3 XSFT (GLX120308 / L16495) VIA AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). A BALLOON CATHETER (UNSPECIFIED BRAND) WAS ALSO USED. THE IMMEDIATE POST-PROCEDURE IMAGING INFORMATION WAS NOT ENTERED INTO THE CRF. THE PATIENT DID NOT EXPERIENCE AN INTRA-OPERATIVE ANEURYSM RUPTURE OR THROMBOEMBOLIC EVENT. THE PATIENT WAS DISCHARGED HOME ON 07-OCT-2021. ON (B)(6) 2022, THE PATIENT HAD A MAGNETIC RESONANCE ANGIOGRAPHY (MRA) AS PART OF THE 180-DAY FOLLOW-UP, WHICH SHOWED A MODIFIED RAYMOND-ROY CLASSIFICATION OF CLASS IIIA: RESIDUAL ANEURYSM WITH CONTRAST WITHIN COIL INTERSTICES. THIS EVENT (ALSO MENTIONED IN THE ADVERSE EVENT LOG AS ANEURYSM REMNANT RETREATED) WAS ASSESSED BY THE PRINCIPAL INVESTIGATOR AS MILD IN SEVERITY, SERIOUS, AND POSSIBLY RELATED TO THE STUDY DEVICE. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2022 TO (B)(6) 2022. THE EVENT WAS TREATED STENT PLACEMENT AND COILING. THE PATIENT RECOVERED AND THE EVENT WAS RESOLVED ON (B)(6) 2022. ON 22-MAR-2022 THE 180-DAY IN-CLINIC FOLLOW-UP VISIT WAS PERFORMED. THE PATIENT¿S MODIFIED RANKIN SCALE (MRS) SCORE WAS ASSESSED AS 2. ON 23-NOV-2022, MODIFIED ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT RETREATMENT OF THE TARGET ANEURYSM DUE TO RESIDUAL ANEURYSM; THE RETREATMENT WAS WITH A CERENOVUS COIL THAT IS NOT PART OF THE STUDY AND A PCONUS STENT (PHENOX). PER THE PRINCIPAL INVESTIGATOR (PI), THE RETREATMENT WAS NOT A DEVICE-RELATED SERIOUS ADVERSE EVENT. THE PATIENT WAS ADMITTED ON (B)(6) 2022 AND DISCHARGED TO HOME ¿ SELF-CARE ON (B)(6) 2022. BASED ON COMPLAINT INFORMATION, THE DEVICE REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10380) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. THE DEVICE PERFORMED AS INTENDED AND NO NEW PATIENT CONSEQUENCES HAVE OCCURRED RELATED TO THE USE OF THE DEVICE. PER MODIFIED INFORMATION RECEIVED ON 23-NOV-2022, THE PATIENT HAD RETREATMENT OF THE TARGET ANEURYSM DUE TO A RESIDUAL ANEURYSM, WHICH WAS DOCUMENTED IN THE ¿RETREATMENT OF TARGET ANEURYSM¿ SECTION OF THE CRF. THEREFORE, SINCE THE RELATIONSHIP BETWEEN THE RESIDUAL ANEURYSM AND THE CERENOVUS STUDY COILS CANNOT BE EXCLUDED, THIS EVENT MEETS REPORTING CRITERIA AS A ¿SERIOUS INJURY.¿ THIS IS ONE OF 7 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2022-00569, 3008114965-2022-00785, 3008114965-2022-00786, 3008114965-2022-00787, 3008114965-2022-00788, AND 3008114965-2022-00790. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE MODIFIED INFORMATION RECEIVED ON 28-MAR-2023, RELATED TO THE ADVERSE EVENT THAT WAS RECEIVED ON 15-MAR-2023 AND SUBMITTED AS 3500A SUPPLEMENTAL REPORTS ON 20-MAR-2023. [MODIFIED ADDITIONAL INFORMATION]: ON 28-MAR-2023, THE ADVERSE EVENT ¿ISCHEMIC STROKE POST TREATMENT WITHOUT ANGIOGRAPHIC OCCLUSION¿ THAT WAS ADDED ON 15-MAR-2023 WAS INACTIVATED FROM THE CASE REPORT FORM (CRF). THE EVENT WAS ADDED IN ERROR. THE DEVICE PERFORMED AS INTENDED AND NO NEW PATIENT CONSEQUENCES HAVE OCCURRED RELATED TO THE USE OF THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED ON 28-MAR-2023, THE ADVERSE EVENT OF "ISCHEMIC STROKE POST-TREATMENT WITHOUT ANGIOGRAPHIC OCCLUSION" WAS INACTIVATED IN THE CRF SINCE IT WAS ENTERED BY ERROR. AS A RESULT, THE PATIENT CODES ¿CEREBRAL INFARCTION¿ AND ¿PROLONGED HOSPITALIZATION¿ WERE REMOVED WITH AN AWARENESS DATE OF 28-MAR-2023. HOWEVER, THE PATIENT HAD RETREATMENT OF THE TARGET ANEURYSM DUE TO A RESIDUAL ANEURYSM, WHICH WAS DOCUMENTED IN THE ¿RETREATMENT OF TARGET ANEURYSM¿ SECTION OF THE CRF, AND THEREFORE, THE EVENT WILL BE CONSERVATIVELY REPORTED TO THE USFDA UNDER TITLE 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. THIS IS ONE OF 7 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2022-00569, 3008114965-2022-00785, 3008114965-2022-00786, 3008114965-2022-00787, 3008114965-2022-00788, 3008114965-2022-00789, AND 3008114965-2022-00790. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE MODIFIED ADDITIONAL EVENT INFORMATION RECEIVED ON 15-MAR-2023. [ADDITIONAL INFORMATION]: MODIFIED ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 15-MAR-2023. THE INFORMATION INDICATED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT: ISCHEMIC STROKE POST-TREATMENT WITHOUT ANGIOGRAPHY OCCLUSION ON (B)(6) 2021. THE PRINCIPAL INVESTIGATOR (PI) DETERMINED THE EVENT TO BE SERIOUS AND SEVERE. IT WAS DETERMINED NOT TO BE RELATED TO THE STUDY DEVICE. THE PATIENT HOSPITALIZATION WAS PROLONGED; THE PATIENT WAS DISCHARGED ON (B)(6) 2021. THE PATIENT OUTCOME WAS RECOVERED/RESOLVED. PER ADDITIONAL INFORMATION RECEIVED ON 15-MAR-2023, THE PATIENT EXPERIENCED AN ISCHEMIC STROKE POST-TREATMENT WITHOUT ANGIOGRAPHY OCCLUSION ON THE SAME DAY AS THE COIL EMBOLIZATION PROCEDURE. THE PI ASSESSED THIS EVENT AS SEVERE IN SEVERITY, SERIOUS (DUE TO PROLONGED HOSPITALIZATION), AND NOT RELATED TO THE STUDY DEVICE. HOWEVER, SINCE THE DEVICE WAS IN USE, AND THEREFORE COULD BE A REMOTE FACTOR, THE EVENT WILL BE CONSERVATIVELY REPORTED TO THE USFDA UNDER TITLE 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY¿ AND AN AWARENESS DATE OF 15-MAR-2023. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. THIS IS ONE OF 7 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2022-00569, 3008114965-2022-00785, 3008114965-2022-00786, 3008114965-2022-00787, 3008114965-2022-00788, 3008114965-2022-00789, AND 3008114965-2022-00790. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 54-YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION AND BEING A CURRENT SMOKER, UNDERWENT COIL EMBOLIZATION OF A MIDLINE RUPTURED ANEURYSM IN THE BIFURCATION OF THE ANTERIOR COMMUNICATING ARTERY WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0 AND A HUNT & HESS GRADE OF 3 (DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT) ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 8MM, DOME 6MM, MAXIMUM ANEURYSM DIAMETER 8MM, NECK SIZE 5MM, AND THE DOME-TO-NECK RATIO OF 1.2MM. THE PARENT VESSEL DIAMETER WAS 2.7MM. BASED ON THE MODIFIED INFORMATION RECEIVED ON (B)(6) 2022, COIL EMBOLIZATION WAS PERFORMED AND THE FOLLOWING COILS WERE IMPLANTED: AN 8MM X 16.1CM MICRUSFRAME 10 (MFR100816 / L15372), A 5MM X 15CM GALAXY G3 (GLY120515 / 30517632), A 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535 / K10121), A 6MM X 11.9CM MICRUSFRAME 10 (MFR100611 / L16158), A 5MM X 15CM GALAXY G3 (GLY120515 / K10721), A 4MM X 10CM GALAXY G3 XSFT (GLX120410 / K10380), AND A 3MM X 8CM GALAXY G3 XSFT (GLX120308 / L16495) VIA AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). A BALLOON CATHETER (UNSPECIFIED BRAND) WAS ALSO USED. THE IMMEDIATE POST-PROCEDURE IMAGING INFORMATION WAS NOT ENTERED INTO THE CRF. THE PATIENT DID NOT EXPERIENCE AN INTRA-OPERATIVE ANEURYSM RUPTURE OR THROMBOEMBOLIC EVENT. THE PATIENT WAS DISCHARGED HOME ON 07-OCT-2021. ON 15-MAR-2022, THE PATIENT HAD A MAGNETIC RESONANCE ANGIOGRAPHY (MRA) AS PART OF THE 180-DAY FOLLOW-UP, WHICH SHOWED A MODIFIED RAYMOND-ROY CLASSIFICATION OF CLASS IIIA: RESIDUAL ANEURYSM WITH CONTRAST WITHIN COIL INTERSTICES. THIS EVENT (ALSO MENTIONED IN THE ADVERSE EVENT LOG AS ANEURYSM REMNANT RETREATED) WAS ASSESSED BY THE PRINCIPAL INVESTIGATOR AS MILD IN SEVERITY, SERIOUS, AND POSSIBLY RELATED TO THE STUDY DEVICE. THE PATIENT WAS HOSPITALIZED FROM 24-MAY-2022 TO 26-MAY-2022. THE EVENT WAS TREATED STENT PLACEMENT AND COILING. THE PATIENT RECOVERED AND THE EVENT WAS RESOLVED ON (B)(6) 2022. ON (B)(6) 2022 THE 180-DAY IN-CLINIC FOLLOW-UP VISIT WAS PERFORMED. THE PATIENT¿S MODIFIED RANKIN SCALE (MRS) SCORE WAS ASSESSED AS 2. ON (B)(6) 2022, MODIFIED ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT RETREATMENT OF THE TARGET ANEURYSM DUE TO RESIDUAL ANEURYSM; THE RETREATMENT WAS WITH A CERENOVUS COIL THAT IS NOT PART OF THE STUDY AND A PCONUS STENT (PHENOX). PER THE PRINCIPAL INVESTIGATOR (PI), THE RETREATMENT WAS NOT A DEVICE-RELATED SERIOUS ADVERSE EVENT. THE PATIENT WAS ADMITTED ON (B)(6) 2022 AND DISCHARGED TO HOME ¿ SELF-CARE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2403831 GALAXY G3 XSFT 4MM X 10CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLX120410 K10380 10886704077718

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention BALLOON CATHETER (UNSPECIFIED BRAND)| ECHELON¿ 10 MICROCATHETER (MEDTRONIC)| GALAXY G3 5MM X 15CM| GALAXY G3 5MM X 15CM| GALAXY G3 XSFT 2.5MM X 3.5CM| GALAXY G3 XSFT 3MM X 8CM| MICRUSFRAME10 6MM X 11.9CM| MICRUSFRAME10 8MM X 16.1CM