BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY G3 MINI 2MM X 4CM

    MDR report key: 12013586 · Received June 16, 2021

    Report

    Report Number
    3008114965-2021-00232
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    May 7, 2021
    Report Date
    June 1, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080305
    PMA / PMN Number
    K171862
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT DATE OF BIRTH, RACE, AND ETHNICITY 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 MALE PATIENT WITH A HISTORY OF ANKYLOSING SPONDYLITIS UNDERWENT COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY BIFURCATION ANEURYSM ON (B)(6) 2020. THE HUNT & HESS GRADE SCORE WAS A 2 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. AT THE 180-DAY (6-MONTH) FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED ON (B)(6) 2021 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. MRS SCORE WAS UNCHANGED. ON (B)(6) 2021, THE PATIENT UNDERWENT RETREATMENT OF THE TARGET ANEURYSM DUE TO THE RESIDUAL ANEURYSM. THREE COMPETITOR COILS WERE IMPLANTED WITH RAYMOND-ROY CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED INTRAOPERATIVE ADVERSE EVENTS. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2020 REVEALED A RUPTURED ANTERIOR COMMUNICATING ARTERY SACCULAR ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.2MM, DOME 5.7MM, MAXIMUM ANEURYSM DIAMETER 7.0MM, NECK SIZE 4.3MM, AND DOME-TO-NECK RATIO 1.3MM. THE PARENT VESSEL DIAMETER WAS 3.0MM. COIL EMBOLIZATION WAS THEN PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 8CM GALAXY G3 MINI (GLM930080 / K10374), ONE 5MM X 15CM GALAXY G3 (GLY120515 / 30392849), ONE 2MM X 4CM GALAXY G3 MINI (GLM920040 / K10049), AND ONE 2MM X 3CM GALAXY G3 MINI (GLM920030 / K10128) VIA AN SL-10® MICROCATHETER (STRYKER). ACCORDING TO THE INFORMATION ENTERED IN THE CASE REPORT FORM (CRF), MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED SIX TIMES DURING THE PROCEDURE (THE EXACT COIL INVOLVED IN EACH OF THE INSTANCES WAS NOT REPORTED IN CRF). 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 ANGIOSUITE PACKING DENSITY 16%. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE OBLITERATION. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS OR STUDY DEVICE DEFICIENCIES. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2020 WITH MRS SCORE OF 0. ON 08 JUNE 2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS EVIDENCE OF COIL COMPACTION ASSOCIATED WITH THE REPORTED ANEURYSM RECANALIZATION DUE TO IT BEING A COMPLEX, WIDE NECKED ANTERIOR COMMUNICATING ARTERY ANEURYSM. THERE WERE SIX (6) INSTANCES OF MICROCATHETER KICK BACK. THE ADDITIONAL INFORMATION INDICATED THAT THESE KICKBACK INSTANCES WERE LIKELY ASSOCIATED WITH THE FIRST COIL OR FIRST TWO COILS. ON 09 JUNE 2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE FIRST COIL USED WAS THE 5MM X 15CM GALAXY G3 (GLY120515 / 30392849) AND THE SECOND COIL WAS THE 3MM X 8CM GALAXY G3 MINI (GLM930080 / K10374). THESE WERE THE TWO COILS THAT WAS REPORTEDLY ASSOCIATED WITH THE SIX INSTANCES OF MICROCATHETER KICKBACK. BASED ON COMPLAINT INFORMATION, THE DEVICE REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10049) 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. 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, 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. IT WAS FURTHER STATED THAT STRICT FOLLOW-UP PLANS SHOULD BE CREATED FOR INTRACRANIAL SACCULAR ANEURYSM (ISA) PATIENTS HAVING THESE HIGH-RISK FACTORS. SINCE THE ANEURYSM RECANALIZATION NECESSITATED SURGICAL RE-TREATMENT TO PREVENT FURTHER INJURY OR COMPLICATIONS, THE EVENT MEETS MDR REPORTING CRITERIA AS A ¿SERIOUS INJURY¿ FOR ALL IMPLANTED CERENOVUS COILS. 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 FOUR (4) PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2021-00230, 3008114965-2021-00231, AND 3008114965-2021-00233. 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 ANKYLOSING SPONDYLITIS UNDERWENT COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY BIFURCATION ANEURYSM ON (B)(6) 2020. THE HUNT & HESS GRADE SCORE WAS A 2 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. AT THE 180-DAY (6-MONTH) FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED ON (B)(6) 2021 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. MRS SCORE WAS UNCHANGED. ON (B)(6) 2021, THE PATIENT UNDERWENT RETREATMENT OF THE TARGET ANEURYSM DUE TO THE RESIDUAL ANEURYSM. THREE COMPETITOR COILS WERE IMPLANTED WITH RAYMOND-ROY CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED INTRAOPERATIVE ADVERSE EVENTS. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2020 REVEALED A RUPTURED ANTERIOR COMMUNICATING ARTERY SACCULAR ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.2MM, DOME 5.7MM, MAXIMUM ANEURYSM DIAMETER 7.0MM, NECK SIZE 4.3MM, AND DOME-TO-NECK RATIO 1.3MM. THE PARENT VESSEL DIAMETER WAS 3.0MM. COIL EMBOLIZATION WAS THEN PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 8CM GALAXY G3 MINI (GLM930080 / K10374), ONE 5MM X 15CM GALAXY G3 (GLY120515 / 30392849), ONE 2MM X 4CM GALAXY G3 MINI (GLM920040 / K10049), AND ONE 2MM X 3CM GALAXY G3 MINI (GLM920030 / K10128) VIA AN SL-10® MICROCATHETER (STRYKER). ACCORDING TO THE INFORMATION ENTERED IN THE CASE REPORT FORM (CRF), MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED SIX TIMES DURING THE PROCEDURE (THE EXACT COIL INVOLVED IN EACH OF THE INSTANCES WAS NOT REPORTED IN CRF). 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 ANGIOSUITE PACKING DENSITY 16%. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE OBLITERATION. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS OR STUDY DEVICE DEFICIENCIES. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2020 WITH MRS SCORE OF 0. ON 08 JUNE 2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS EVIDENCE OF COIL COMPACTION ASSOCIATED WITH THE REPORTED ANEURYSM RECANALIZATION DUE TO IT BEING A COMPLEX, WIDE NECKED ANTERIOR COMMUNICATING ARTERY ANEURYSM. THERE WERE SIX (6) INSTANCES OF MICROCATHETER KICK BACK. THE ADDITIONAL INFORMATION INDICATED THAT THESE KICKBACK INSTANCES WERE LIKELY ASSOCIATED WITH THE FIRST COIL OR FIRST TWO COILS. ON 09 JUNE 2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE FIRST COIL USED WAS THE 5MM X 15CM GALAXY G3 (GLY120515 / 30392849) AND THE SECOND COIL WAS THE 3MM X 8CM GALAXY G3 MINI (GLM930080 / K10374). THESE WERE THE TWO COILS THAT WAS REPORTEDLY ASSOCIATED WITH THE SIX INSTANCES OF MICROCATHETER KICKBACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906431 GALAXY G3 MINI 2MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM920040 K10049 10886704080305

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention