BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY G3 MINI 1.5MM X 2CM

    MDR report key: 12368690 · Received August 25, 2021

    Report

    Report Number
    3008114965-2021-00416
    Event Type
    Injury
    Date Received
    August 25, 2021
    Date of Event
    July 12, 2021
    Report Date
    August 9, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080138
    PMA / PMN Number
    K171862
    Adverse Event
    Yes
    Product Problem
    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 AND ETHNICITY WERE NOT PROVIDED. PROCODE IS KRD/HCG. THE PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / REPORTED. [CONCLUSION]: THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD MALE PATIENT WITH A HISTORY OF APPENDECTOMY AND INTRACRANIAL ANEURYSMS (2 TOTAL) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) (HUNT & HESS GRADE 1) ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT ACOM BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 3.9MM, DOME 5.0MM, MAXIMUM ANEURYSM DIAMETER 5.0MM, NECK SIZE 2.5MM, AND DOME-TO-NECK RATIO 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.2MM. COIL EMBOLIZATION WAS THEN PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 4CM GALAXY G3 XSFT (GLX120304 / L16812), TWO 2MM X 3CM GALAXY G3 MINI (GLM920030 / K10499), TWO 1.5MM X 2CM GALAXY G3 MINI (GLM915020 / 30360290), TWO 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / K10660), AND TWO 1MM X 3CM GALAXY G3 MINI (GLM910030 / K10700) VIA AN SL-10 MICROCATHETER (STRYKER). PER THE INFORMATION DOCUMENTED ON THE CASE REPORT FORM (CRF), ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / K10315) COIL WAS USED BUT NOT IMPLANTED. THERE WAS NO MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) EXPERIENCED. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. 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 38% ANGIOSUITE PACKING DENSITY. 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 INTRAOPERATIVE COMPLICATIONS OR STUDY DEVICE DEFICIENCIES. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2020. THE 180-DAY (6-MONTH) FOLLOW-UP VISIT WAS CONDUCTED BY PHONE ON (B)(6) 2020. MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED AT THE 1-YEAR FOLLOW-UP ON (B)(6) 2021 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS II. MRS SCORE WAS 0. THE PATIENT UNDERWENT RETREATMENT OF THE TARGET ANEURYSM DUE TO RESIDUAL NECK ON (B)(6) 2021. TWO NEUROFORM ATLAS STENTS (STRYKER) AND 13 TARGET (STRYKER) COILS WERE IMPLANTED WITH FINAL MODIFIED RAYMOND-ROY SCORE OF CLASS I: COMPLETE = COMPLETE OBLITERATION. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED ON 24 AUGUST 2021 INDICATED THAT THERE WAS EVIDENCE OF COIL COMPACTION AT THE TIME OF THE ANEURYSM RETREATMENT. HOWEVER, THERE WAS NO OVERALL CHANGE IN MODIFIED RAYMOND-ROY CLASSIFICATION SCORE. THE 10TH COIL LISTED IS THE 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / K10315) COULD NOT BE PLACED WITHIN THE ANEURYSM NECK DUE TO PROLAPSE OF LOOPS INTO THE PARENT VESSEL. THE COMPLAINT COILS REMAIN IMPLANTED IN THE PATIENT AND ARE NOT AVAILABLE FOR EVALUATION. BASED ON COMPLAINT INFORMATION, THE DEVICE REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (30360290) 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. 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 MANUFACTURING ISSUES RELATED TO THE EVENT. SINCE THE ALLEGED COIL COMPACTION WITH 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: 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. ¿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 10 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2021-00413, 3008114965-2021-00414, 3008114965-2021-00415, 3008114965-2021-00417, 3008114965-2021-00418, 3008114965-2021-00419, 3008114965-2021-00420, 3008114965-2021-00421, AND 3008114965-2021-00422. 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 MALE PATIENT WITH A HISTORY OF APPENDECTOMY AND INTRACRANIAL ANEURYSMS (2 TOTAL) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) (HUNT & HESS GRADE 1) ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT ACOM BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 3.9MM, DOME 5.0MM, MAXIMUM ANEURYSM DIAMETER 5.0MM, NECK SIZE 2.5MM, AND DOME-TO-NECK RATIO 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.2MM. COIL EMBOLIZATION WAS THEN PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 4CM GALAXY G3 XSFT (GLX120304 / L16812), TWO 2MM X 3CM GALAXY G3 MINI (GLM920030 / K10499), TWO 1.5MM X 2CM GALAXY G3 MINI (GLM915020 / 30360290), TWO 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / K10660), AND TWO 1MM X 3CM GALAXY G3 MINI (GLM910030 / K10700) VIA AN SL-10 MICROCATHETER (STRYKER). PER THE INFORMATION DOCUMENTED ON THE CASE REPORT FORM (CRF), ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / K10315) COIL WAS USED BUT NOT IMPLANTED. THERE WAS NO MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) EXPERIENCED. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. 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 38% ANGIOSUITE PACKING DENSITY. 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 INTRAOPERATIVE COMPLICATIONS OR STUDY DEVICE DEFICIENCIES. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2020. THE 180-DAY (6-MONTH) FOLLOW-UP VISIT WAS CONDUCTED BY PHONE ON (B)(6) 2020. MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED AT THE 1-YEAR FOLLOW-UP ON (B)(6) 2021 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS II. MRS SCORE WAS 0. THE PATIENT UNDERWENT RETREATMENT OF THE TARGET ANEURYSM DUE TO RESIDUAL NECK ON (B)(6) 2021. TWO NEUROFORM ATLAS STENTS (STRYKER) AND 13 TARGET (STRYKER) COILS WERE IMPLANTED WITH FINAL MODIFIED RAYMOND-ROY SCORE OF CLASS I: COMPLETE = COMPLETE OBLITERATION. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED ON 24 AUGUST 2021 INDICATED THAT THERE WAS EVIDENCE OF COIL COMPACTION AT THE TIME OF THE ANEURYSM RETREATMENT. HOWEVER, THERE WAS NO OVERALL CHANGE IN MODIFIED RAYMOND-ROY CLASSIFICATION SCORE. THE 10TH COIL LISTED IS THE 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / K10315) COULD NOT BE PLACED WITHIN THE ANEURYSM NECK DUE TO PROLAPSE OF LOOPS INTO THE PARENT VESSEL. THE COMPLAINT COILS REMAIN IMPLANTED IN THE PATIENT AND ARE NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265620 GALAXY G3 MINI 1.5MM X 2CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM915020 30360290 10886704080138

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention