BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUSFRAME10 4MM X 7.5CM

    MDR report key: 12302334 · Received August 10, 2021

    Report

    Report Number
    3008114965-2021-00354
    Event Type
    Injury
    Date Received
    August 10, 2021
    Date of Event
    July 21, 2021
    Report Date
    July 28, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077824
    PMA / PMN Number
    K150319
    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 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 A HISTORY OF HEADACHES, CONTROLLED HYPERTENSION, ACTIVE SMOKING, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), AND RHEUMATOID ARTHRITIS UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM ON (B)(6) 2020. 180-DAY (6-MONTH) FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED ON (B)(6) 2021 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS II: RESIDUAL NECK = PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL BUT WITHOUT OPACIFICATION OF THE ANEURYSMAL SAC. MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. A PIPELINE FLOW DIVERTER WAS IMPLANTED DUE TO INCREASE IN ANEURYSM SIZE ON (B)(6) 2021. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS. MODIFIED RAYMOND-ROY CLASSIFICATION FOR THE TARGET ANEURYSM FOLLOWING RETREATMENT WAS CLASS II. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON THE FOLLOWING DAY. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2020 REVEALED AN UNRUPTURED ANEURYSM ON THE RIGHT SIDEWALL OF THE ICA WITH THE FOLLOWING DIMENSIONS: HEIGHT 4.5MM, DOME 5.9MM, MAXIMUM ANEURYSM DIAMETER 5.9MM, NECK SIZE 3.0MM, AND DOME-TO-NECK RATIO 2.0MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. COIL EMBOLIZATION WAS THEN PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 7.5CM MICRUSFRAME10 (MFR100407 / L17159), ONE 3.5MM X 7.5CM GALAXY G3 XSFT (GLX123575 / L16383), ONE 2.5MM X 5CM GALAXY G3 XSFT (GLX122505 / K10422), ONE 2MM X 3CM GALAXY G3 MINI (GLM920030 / L16190), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020 / L17140), AND ONE 3MM X 10CM TARGET COIL (STRYKER) VIA AN SL-10® MICROCATHETER (STRYKER). 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 29% ANGIOSUITE PACKING DENSITY. 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 THE FOLLOWING DAY. THE 180-DAY (6-MONTH) FOLLOW-UP VISIT WAS CONDUCTED IN THE CLINIC ON (B)(6) 2021. DSA DEMONSTRATED INCREASE IN ANEURYSM SIZE REQUIRING RETREATMENT ON (B)(6) 2021. THE COMPLAINT COILS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. ON 05 AUGUST 2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS EVIDENCE OF COIL COMPACTION ASSOCIATED WITH THE ANEURYSM RECANALIZATION. BASED ON COMPLAINT INFORMATION, THE DEVICE REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L17159) 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 ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD 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 LITERATURE 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. 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 REPORTED ANEURYSM RECANALIZATION. SINCE THE ALLEGED 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. REFERENCE: ¿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. THIS IS ONE OF 5 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2021-00355, 3008114965-2021-00356, 3008114965-2021-00357, AND 3008114965-2021-00358. 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 A HISTORY OF HEADACHES, CONTROLLED HYPERTENSION, ACTIVE SMOKING, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), AND RHEUMATOID ARTHRITIS UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM ON (B)(6) 2020. 180-DAY (6-MONTH) FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED ON (B)(6) 2021 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS II: RESIDUAL NECK = PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL BUT WITHOUT OPACIFICATION OF THE ANEURYSMAL SAC. MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. A PIPELINE FLOW DIVERTER WAS IMPLANTED DUE TO INCREASE IN ANEURYSM SIZE ON (B)(6) 2021. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS. MODIFIED RAYMOND-ROY CLASSIFICATION FOR THE TARGET ANEURYSM FOLLOWING RETREATMENT WAS CLASS II. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON THE FOLLOWING DAY. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2020 REVEALED AN UNRUPTURED ANEURYSM ON THE RIGHT SIDEWALL OF THE ICA WITH THE FOLLOWING DIMENSIONS: HEIGHT 4.5MM, DOME 5.9MM, MAXIMUM ANEURYSM DIAMETER 5.9MM, NECK SIZE 3.0MM, AND DOME-TO-NECK RATIO 2.0MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. COIL EMBOLIZATION WAS THEN PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 7.5CM MICRUSFRAME10 (MFR100407 / L17159), ONE 3.5MM X 7.5CM GALAXY G3 XSFT (GLX123575 / L16383), ONE 2.5MM X 5CM GALAXY G3 XSFT (GLX122505 / K10422), ONE 2MM X 3CM GALAXY G3 MINI (GLM920030 / L16190), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020 / L17140), AND ONE 3MM X 10CM TARGET COIL (STRYKER) VIA AN SL-10® MICROCATHETER (STRYKER). 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 29% ANGIOSUITE PACKING DENSITY. 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 THE FOLLOWING DAY. THE 180-DAY (6-MONTH) FOLLOW-UP VISIT WAS CONDUCTED IN THE CLINIC ON (B)(6) 2021. DSA DEMONSTRATED INCREASE IN ANEURYSM SIZE REQUIRING RETREATMENT ON (B)(6) 2021. THE COMPLAINT COILS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. ON 05 AUGUST 2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS EVIDENCE OF COIL COMPACTION ASSOCIATED WITH THE ANEURYSM RECANALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200818 MICRUSFRAME10 4MM X 7.5CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL MFR100407 L17159 10886704077824

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention