BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY G3 MINI 2.5MM X 3.5CM

    MDR report key: 12366437 · Received August 25, 2021

    Report

    Report Number
    3008114965-2021-00385
    Event Type
    Injury
    Date Received
    August 25, 2021
    Date of Event
    January 26, 2021
    Report Date
    January 29, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080268
    PMA / PMN Number
    K171862
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT DATE OF BIRTH, WEIGHT, AND RACE WERE NOT PROVIDED. PROCODE IS KRD/HCG. THE INITIAL REPORTER PHONE AND EMAIL ADDRESS ARE NOT AVAILABLE / REPORTED. [CONCLUSION]: THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD FEMALE PATIENT WITH NO REPORTED RELEVANT MEDICAL HISTORY UNDERWENT COIL EMBOLIZATION OF A LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) (ANTERIOR CIRCULATION) ANEURYSM ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 4.3MM, DOME 3.7MM, MAXIMUM ANEURYSM DIAMETER 4.5MM, NECK SIZE 3.2MM, AND DOME-TO-NECK RATIO 1.2MM. THE PARENT VESSEL DIAMETER WAS 1.4MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 6CM GALAXY G3 XSFT (GLX120406 / K10045), ONE 3MM X 4CM GALAXY G3 MINI (GLM930040 / L17272), ONE 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035 / L15184), ONE 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035 / S15122), ONE 2MM X 3CM GALAXY G3 MINI (GLM920030 / L13933), AND ONE COMANECI STENT VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). INTRAOPERATIVELY A SEVERE THROMBOEMBOLIC EVENT OCCURRED. PER THE PRINCIPAL INVESTIGATOR THE EVENT WAS CONSIDERED SERIOUS HOWEVER NOT RELATED TO THE STUDY DEVICE. SURGICAL INTERVENTION OF A THROMBECTOMY AND AGGROSTAT MEDICATION ADMINISTRATION WAS REQUIRED AND THE OUTCOME WAS RECOVERED/RESOLVED ON (B)(6) 2021. MODIFIED INFORMATION RECEIVED ON 29 APRIL 2021 WAS REVIEWED. THE AE ¿INTRA OPERATIVE THROMBOEMBOLIC EVENT¿ WAS INACTIVATED ON (B)(6) 2021 DUE TO REASON CODE ¿ADDED IN ERROR¿. THE STUDY LEAD CONFIRMED WITH THE SITE THAT THE PATIENT WAS ASYMPTOMATIC; THEREFORE, THE EVENT DID NOT MEET STUDY PROTOCOL REPORTING CRITERIA. ELECTRONIC DATA CAPTURE (EDC) WAS RE-REVIEWED. THE PATIENT INITIALLY PRESENTED WITH A HISTORY OF CONTROLLED HYPERTENSION AND CLASS 3 OBESITY (BMI 55 KG/M2). IMMEDIATELY FOLLOWING THE STUDY PROCEDURE ON (B)(6) 2021, THE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE OBLITERATION. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH 27% ANGIOSUITE PACKING DENSITY. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. MODIFIED INFORMATION RECEIVED ON 11 AUGUST 2021 WAS REVIEWED. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED AT THE 6-MONTH FOLLOW-UP VISIT ON (B)(6) 2021 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. MODIFIED RANKIN SCALE (MRS) SCORE WAS 2. THE PATIENT SUBSEQUENTLY UNDERWENT SURGICAL RETREATMENT OF THE TARGET ANEURYSM DUE TO INCREASE IN ANEURYSM SIZE ON (B)(6) 2021. A PIPELINE FLOW DIVERTER (MEDTRONIC) AND 10 AXIUM 3D COILS (MEDTRONIC) WERE IMPLANTED WITH FINAL MODIFIED RAYMOND ROY CLASSIFICATION SCORE OF CLASS IIIB. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS, AND THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED ON 24 AUGUST 2021 INDICATED THAT THERE WAS COIL COMPACTION ASSOCIATED WITH THE ANEURYSM REGROWTH. BASED ON COMPLAINT INFORMATION, THE DEVICE REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L15184) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. PRODUCT EVALUATION AND ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD NOT BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. THROMBOEMBOLISM IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF EMBOLIC COILS IN CEREBRAL ANEURYSMS AND IS LISTED IN THE IFU AS SUCH. WITH THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT; HOWEVER, CLINICAL, PHARMACOLOGICAL, AND PROCEDURAL FACTORS INCLUDING THIS PATIENT¿S PRE-PROCEDURE PRESENTATION WITH A RUPTURED ANEURYSM MAY HAVE CONTRIBUTED TO THE EVENT. THERE HAVE BEEN STUDIES SHOWING EVIDENCE FOR A GENERALIZED STRONG ACTIVATION OF THE COAGULATION AND FIBRINOLYTIC SYSTEM IN PATIENTS WITH SUBARACHNOID HEMORRHAGE. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE REPORTED EVENT. SINCE THE INVESTIGATOR FELT THAT THE INTRAOPERATIVE THROMBOEMBOLIC EVENT WAS NOT RELATED TO THE STUDY DEVICE (S), THE EVENT DOES NOT MEET MDR REPORTING CRITERIA. COIL COMPACTION WITH ANEURYSM RECANALIZATION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH COIL EMBOLIZATION PROCEDURES. COIL COMPACTION IS THE DECREASE IN INTERSPACES BETWEEN THE LOOPS OF THE COILS, WHICH LEADS TO SMALLER COIL MESH. IT OCCURS OVER TIME AFTER COIL PLACEMENT. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF ROOT CAUSE; HOWEVER, ACCORDING TO THE REFERENCED PUBLICATION (1), PATIENTS PRESENTING WITH SAH SECONDARY TO RUPTURED ANEURYSMS ARE MORE LIKELY TO DEVELOP RECANALIZATION AFTER COILING PROCEDURES. THE DYNAMIC NATURE OF RUPTURED ANEURYSMS AND CLOT LYSIS APPEARS TO PROMOTE RECANALIZATION. MURAL INSTABILITY AND THE INCREASED PULSATILE PRESSURE OF RUPTURED ANEURYSMS MAY THUS ENCOURAGE GREATER COIL COMPACTION THAN THAT ENCOUNTERED IN UNRUPTURED COUNTERPARTS. LYSIS OF CLOT MAY TAKE PLACE AS WELL WITHIN THROMBUS OR AT RUPTURE SITES ONCE RELATED HYPERCOAGULABILITY SUBSIDES. FURTHERMORE, THE LITERATURE PUBLICATION (2) STATES THAT SMOKING, A LARGE TUMOR SIZE, A WIDE-NECKED ANEURYSM, AN ANTERIOR COMMUNICATING OR MIDDLE CEREBRAL ARTERY ANEURYSM, AN ANEURYSM RUPTURE, A VOLUME EMBOLIZATION RATIO (VER) < 20%, AND AN ABSENCE OF STENT ASSISTANCE ARE SIGNIFICANT RISK FACTORS FOR THE POSTOPERATIVE RECURRENCE OF AN ANEURYSM. THE ARTICLE ALSO WARNS THAT STRICT FOLLOW-UP PLANS SHOULD BE CREATED FOR INTRACRANIAL SACCULAR ANEURYSM (ISA) PATIENTS HAVING THESE HIGH-RISK FACTORS. THERE IS NO INDICATION OF ANY DEVICE DEFECTS OR MANUFACTURING ISSUES RELATED TO THE ANEURYSM RECANALIZATION. SINCE THE COIL COMPACTION WITH ASSOCIATED ANEURYSM RECANALIZATION NECESSITATED SURGICAL RE-TREATMENT TO PRECLUDE PATIENT COMPLICATIONS, THE EVENT MEETS MDR REPORTING CRITERIA FOR ALL IMPLANTED CERENOVUS COILS. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. REFERENCES: 1) RISK FACTOR ANALYSIS OF RECANALIZATION TIMING IN COILED ANEURYSMS: EARLY VERSUS LATE RECANALIZATION. J.P. JEON, Y.D. CHO, D.H. YOO, J. MOON, J. LEE, W.-S. CHO, H.-S. KANG, J.E. KIM AND M.H. HAN. AMERICAN JOURNAL OF NEURORADIOLOGY SEPTEMBER 2017, 38 (9) 1765-1770; DOI: HTTPS://DOI.ORG/10.3174/AJNR.A5267. 2) ¿RISK FACTORS FOR THE RECURRENCE OF AN INTRACRANIAL SACCULAR ANEURYSM FOLLOWING ENDOVASCULAR TREATMENT¿. DE-ZHANG HUANG, BIN JIANG, WEI HE, YI-HUA WANG, AND ZHI-GANG WANG. ONCOTARGET. 2017 MAY 16; 8(20): 33676¿33682. PUBLISHED ONLINE 2017 APR 6. DOI: 10.18632/ONCOTARGET.16897. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. THIS IS ONE OF 5 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2021-00383, 3008114965-2021-00384, 3008114965-2021-00386, AND 3008114965-2021-00387. 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 · 1

    THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD FEMALE PATIENT WITH NO REPORTED RELEVANT MEDICAL HISTORY UNDERWENT COIL EMBOLIZATION OF A LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) (ANTERIOR CIRCULATION) ANEURYSM ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 4.3MM, DOME 3.7MM, MAXIMUM ANEURYSM DIAMETER 4.5MM, NECK SIZE 3.2MM, AND DOME-TO-NECK RATIO 1.2MM. THE PARENT VESSEL DIAMETER WAS 1.4MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 6CM GALAXY G3 XSFT (GLX120406 / K10045), ONE 3MM X 4CM GALAXY G3 MINI (GLM930040 / L17272), ONE 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035 / L15184), ONE 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035 / S15122), ONE 2MM X 3CM GALAXY G3 MINI (GLM920030 / L13933), AND ONE COMANECI STENT VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). INTRAOPERATIVELY A SEVERE THROMBOEMBOLIC EVENT OCCURRED. PER THE PRINCIPAL INVESTIGATOR THE EVENT WAS CONSIDERED SERIOUS HOWEVER NOT RELATED TO THE STUDY DEVICE. SURGICAL INTERVENTION OF A THROMBECTOMY AND AGGROSTAT MEDICATION ADMINISTRATION WAS REQUIRED AND THE OUTCOME WAS RECOVERED/RESOLVED ON (B)(6) 2021. MODIFIED INFORMATION RECEIVED ON 29 APRIL 2021 WAS REVIEWED. THE AE ¿INTRA OPERATIVE THROMBOEMBOLIC EVENT¿ WAS INACTIVATED ON 29 APRIL 2021 DUE TO REASON CODE ¿ADDED IN ERROR¿. THE STUDY LEAD CONFIRMED WITH THE SITE THAT THE PATIENT WAS ASYMPTOMATIC; THEREFORE, THE EVENT DID NOT MEET STUDY PROTOCOL REPORTING CRITERIA. ELECTRONIC DATA CAPTURE (EDC) WAS RE-REVIEWED. THE PATIENT INITIALLY PRESENTED WITH A HISTORY OF CONTROLLED HYPERTENSION AND CLASS 3 OBESITY (BMI 55 KG/M2). IMMEDIATELY FOLLOWING THE STUDY PROCEDURE ON (B)(6) 2021, THE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE OBLITERATION. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH 27% ANGIOSUITE PACKING DENSITY. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. MODIFIED INFORMATION RECEIVED ON 11 AUGUST 2021 WAS REVIEWED. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED AT THE 6-MONTH FOLLOW-UP VISIT ON (B)(6) 2021 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. MODIFIED RANKIN SCALE (MRS) SCORE WAS 2. THE PATIENT SUBSEQUENTLY UNDERWENT SURGICAL RETREATMENT OF THE TARGET ANEURYSM DUE TO INCREASE IN ANEURYSM SIZE ON (B)(6) 2021. A PIPELINE FLOW DIVERTER (MEDTRONIC) AND 10 AXIUM 3D COILS (MEDTRONIC) WERE IMPLANTED WITH FINAL MODIFIED RAYMOND ROY CLASSIFICATION SCORE OF CLASS IIIB. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS, AND THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED ON 24 AUGUST 2021 INDICATED THAT THERE WAS COIL COMPACTION ASSOCIATED WITH THE ANEURYSM REGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263429 GALAXY G3 MINI 2.5MM X 3.5CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM925035 L15184 10886704080268

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention COMANECI STENT (RAPID MEDICAL)| EXCELSIOR® SL-10® MICROCATHETER (STRYKER)| GALAXY G3 MINI 2.5MM X 3.5CM| GALAXY G3 MINI 2MM X 3CM| GALAXY G3 MINI 3MM X 4CM| GALAXY G3 XSFT 4MM X 6CM