BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1.5MM X 3CM

    MDR report key: 12368686 · Received August 25, 2021

    Report

    Report Number
    3008114965-2021-00422
    Event Type
    Malfunction
    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
    10886704080145
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (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) 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 WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10315) 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 HERNIATION INTO PARENT VESSEL IS A KNOWN PROCEDURAL OCCURRENCE. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. HOWEVER, THERE ARE CLINICAL AND PROCEDURAL FACTORS INCLUDING ANEURYSM/VESSEL CHARACTERISTICS, DEVICE INTERACTION, DEVICE SELECTION, AND OPERATOR TECHNIQUE THAT MAY HAVE CONTRIBUTED TO THE COIL HERNIATION. COIL PROTRUSION INTO THE PARENT VESSEL DURING POSITIONING MEETS MDR REPORTING CRITERIA AS A ¿MALFUNCTION¿ AS THIS FAILURE COULD RESULT IN NON-TARGET SITE EMBOLIZATION, ISCHEMIA OR INFARCT, OR MAY REQUIRE ADDITIONAL INTERVENTION. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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, 3008114965-2021-00416, 3008114965-2021-00417, 3008114965-2021-00418, 3008114965-2021-00419, 3008114965-2021-00420, 3008114965-2021-00421. INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 (B)(6) STUDY, A (B)(6) 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
    1265616 GALAXY G3 MINI 1.5MM X 3CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM915030 K10315 10886704080145

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR GALAXY G3 MINI 1.5MM X 2CM| GALAXY G3 MINI 1.5MM X 2CM| GALAXY G3 MINI 1.5MM X 3CM| GALAXY G3 MINI 1.5MM X 3CM| GALAXY G3 MINI 1MM X 3CM| GALAXY G3 MINI 1MM X 3CM| GALAXY G3 MINI 2MM X 3CM| GALAXY G3 MINI 2MM X 3CM| GALAXY G3 XSFT 3MM X 4CM| SL-10® MICROCATHETER (STRYKER)