BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY G3 XSFT 3MM X 6CM

    MDR report key: 15714105 · Received November 2, 2022

    Report

    Report Number
    3008114965-2022-00702
    Event Type
    Injury
    Date Received
    November 2, 2022
    Date of Event
    April 8, 2021
    Report Date
    December 1, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077695
    PMA / PMN Number
    K150319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). PATIENT IDENTIFIER: (B)(6). THE DEVICE REMAINS IMPLANTED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30399443 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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 TEN PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2022-00700, 3008114965-2022-00701, 3008114965-2022-00703, 3008114965-2022-00704, 3008114965-2022-00705, 3008114965-2022-00706, 3008114965-2022-00707, 3008114965-2022-00708 AND 3008114965-2022-00709. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, B5, G3, G6, H2, H6 AND H10. SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT DEVELOPED DYSARTHRIA ON (B)(6) 2021 AND THE FAMILY CONTACTED THE HOSPITAL. CEREBRAL INFARCTION WAS SUSPECTED AFTER DIFFUSION WEIGHTED MAGNETIC RESONANCE IMAGING (DWI - MRI) FINDINGS MAINLY IN LEFT DEEP FRONTAL LOBE, AND MRI REVEALED A SUBARACHNOID HEMORRHAGE FROM THE LEFT SYLVIAN FISSURE TO THE AREA SURROUNDING LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE LEFT M1 WAS NARROWED ON MAGNETIC RESONANCE ANGIOGRAPHY (MRA), AND VASOSPASM FINDINGS WERE OBSERVED. THE PATIENT WAS HOSPITALIZED FOR TREATMENT OF VASOSPASM. THE DWI HIGH-SIGNAL REGIONS FOUND ON A HEAD MRI TAKEN ON APRIL 13 HAD ENLARGED, AND OCCURRENCE OF NEW INFARCTS WAS SUSPECTED, BUT THE VASOSPASM OF THE LEFT MIDDLE CEREBRAL ARTERY WAS IMPROVING ON MRA. HOSPITALIZATION WAS EXTENDED AND DRUG ADMINISTRATION WAS CONTINUED BASED ON THE MRI FINDINGS, BUT THE PATIENT¿S GENERAL CONDITION STABILIZED DURING ADMISSION, AND THERE WERE NO NEUROLOGICAL FINDINGS OBSERVED. IT WAS REPORTED THAT EDARAVONE, FASUDIL HYDROCHLORIDE HYDRATE AND ASPIRIN WERE USED DURING HOSPITALIZATION (DOSAGES AND FREQUENCY ARE UNKNOWN). THERE WERE NO NEW INFARCTS FOUND ON AN MRI TAKEN ON (B)(6) 2022, THE LEFT MCA WAS CLEARLY VISUALIZED UP TO DISTAL M1 ON MRA, AND THE PATIENT¿S GENERAL CONDITION WAS GOOD, SO SHE WAS DISCHARGED THE FOLLOWING DAY. AT DISCHARGE, ASPIRIN 100MG, FAMOTIDINE 20MG, CILOSTAZOL 100MG, AND LOXOPROFEN 60MG WERE PRESCRIBED. BASED ON THE REVIEW OF ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2022, THE FOLLOWING HEALTH EFFECT ¿ CLINICAL CODES WERE ADDED: INTERCRANIAL HEMORRHAGE (E0118) AND VASOCONSTRICTION (E0516). HEALTH EFFECT ¿ IMPACT CODE: UNEXPECTED DIAGNOSTIC INTERVENTION (F22). PER THE INFORMATION PROVIDED, THE DEVICE PERFORMED AS INTENDED. HOWEVER, THE PRINCIPAL INVESTIGATOR ASSESSED THE REPORTED ADVERSE EVENT OF ¿CEREBRAL INFARCTION¿ AS POSSIBLY RELATED TO THE STUDY DEVICE. SUBARACHNOID HEMORRHAGE, ARTERIAL SPASM AND CEREBRAL INFARCTION ARE WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH COIL EMBOLIZATION PROCEDURES. IN ADDITION, THE PATIENT WAS HOSPITALIZED AND WAS THE ADVERSE EVENT WAS MEDICALLY TREATED. THEREFORE, 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE STERLING STUDY, A 62-YEAR-OLD FEMALE PATIENT (B)(6) UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY ANTERIOR CIRCULATION ANEURYSM ON (B)(6) 2021. MODIFIED RANKING SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 6.5MM, DOME 4.2MM, MAXIMUM ANEURYSM DIAMETER 7.0MM, NECK SIZE 2.9MM, AND THE DOME-TO-NECK RATIO OF 1.4MM. THE PARENT VESSEL DIAMETER WAS 3.4MM. COIL EMBOLIZATION WAS PERFORMED WITH TEN (10) CERENOVUS COILS: A GALAXY G3 XSFT 5MM X 15CM (GLY120515 / L13767), A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575 /K10486), A GALAXY G3 XSFT 3MM X 6M (GLX120306 /30399443), A GALAXY G3 MINI 2MM X 6CM (GLM920060 /30366491), A GALAXY G3 MINI 1.5MM X 3CM (GLM915030 /L14642), GALAXY G3 MINI 1.5MM X 3CM (GLM915030 /30393176), GALAXY G3 MIMI 1MM X 3CM (GLM910030 /30422323), A GALAXY G3 MIMI 1MM X 2CM (GLM910020 /K10600), A GALAXY G3 MIMI 1MM X 2CM (GLM910020 /30390764) AND A 1MM X 1.5CM GALAXY G3 MIMI (GLM910015, 30390761) WERE IMPLANTED. A LVIS STENT (MICROVENTION) WAS ALSO IMPLANTED, AND A BALLOON CATHETER (UNKNOWN CATALOG/MANUFACTURER) WAS ALSO USED. ALL COILS WERE IMPLANTED VIA A HEADWAY 17 MICROCATHETER. 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 WITH A PACKING DENSITY WITHOUT G3 MINI COILS (USING ANGIOSUITE) WAS 20% AND AT THE CONCLUSION OF THE PROCEDURE (USING ANGIOSUITE) WAS 29%. THE 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 ANEURYSM SAC. THERE WERE NO REPORTED STUDY DEVICE DEFICIENCIES OR INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2021 WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0. THE 180-DAY (6-MONTH) FOLLOW-UP VISIT WAS PERFORMED IN THE CLINIC ON (B)(6) 2021 WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WAS PERFORMED AND SHOWED A MODIFIED RAYMOND-ROY CLASSIFICATION CLASS II SCORE; THE STATUS OF THE ANEURYSM DIDN¿T CHANGED SINCE THE DISCHARGE, I.E. NO NEWLY RUPTURED OR RE-RUPTURED ANEURYSM. THE 1-YEAR FOLLOW-UP VISIT WAS PERFORMED ON (B)(6) 2022 WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0. DSA WAS PERFORMED AT THIS YEAR 1 FOLLOW-UP AND SHOWED A COMPLETE OBLITERATION OF THE ANEURYSM - MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS I. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT EXPERIENCED A BRAIN INFARCTION WITH A SEVERITY OF MODERATE. THE ADVERSE EVENT WAS CLASSIFIED AS SERIOUS, RESULTING IN IN-PATIENT OR PROLONGED HOSPITALIZATION. THE ADMISSION DATE WAS (B)(6) 2021 AND DISCHARGE DATE WAS (B)(6) 2021. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. THE RELATIONSHIP TO THE STUDY DEVICE WAS DEEMED POSSIBLE. IN THE OPINION OF THE PRINCIPAL INVESTIGATOR, THE ADVERSE EVENT WAS EXPECTED/ANTICIPATED. THE EVENT RECOVERED/RESOLVED ON (B)(6) 2021. THE ADVERSE EVENT DID NOT RESULT IN THE SUBJECT¿S DISCONTINUATION FROM THE STUDY. THE EVENT WAS MEDICALLY TREATED ONLY. PER THE CASE REPORT FORM (CRF) UNDER HOSPITALIZATION DATE, THE EVENT DESCRIPTION WAS LISTED AS CEREBRAL VASOSPASM (ALTHOUGH PRINCIPAL DIAGNOSIS WAS ICD-10 G459 - TRANSIENT CEREBRAL ISCHEMIC ATTACK, UNSPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275603 GALAXY G3 XSFT 3MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLX120306 30399443 10886704077695

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention BALLOON CATHETER (UNKNOWN CATALOG/MANUFACTURER).| GALAXY G3 5MM X 15CM.| GALAXY G3 MINI 1.5MM X 3CM.| GALAXY G3 MINI 1.5MM X 3CM.| GALAXY G3 MINI 1MM X 1.5CM.| GALAXY G3 MINI 1MM X 2CM.| GALAXY G3 MINI 1MM X 2CM.| GALAXY G3 MINI 1MM X 3CM.| GALAXY G3 MINI 2MM X 6CM.| GALAXY G3 XSFT 3.5MM X 7.5CM.| HEADWAY 17 MICROCATHETER.| LVIS STENT (MICROVENTION).