BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY G3 XSFT 4MM X 8CM

    MDR report key: 10239854 · Received July 7, 2020

    Report

    Report Number
    3008114965-2020-00268
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    May 7, 2020
    Report Date
    June 19, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077732
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENTS OF CAPSULAR CONTRACTURE BAKER GRADE III AND LYMPHADENOPATHY ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: CAPSULAR CONTRACTURE BAKER GRADE III AND LYMPHADENOPATHY.

    Description of Event or Problem · 1

    AS REPORTED BY THE STERLING STUDY, A 35-YEAR OLD MALE (SUBJECT 913-004) WITH A HISTORY OF HEADACHES AND SMOKING (CURRENT) UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RIGHT POSTERIOR CEREBRAL ARTERY ANEURYSM ON 19-SEP-2019 AND EXPERIENCED ANEURYSM RECANALIZATION ON 07-MAY-2020 REQUIRING REPEAT COIL EMBOLIZATION ON 09-JUN-2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON 19-SEP-2019 REVEALED A RIGHT PCA BIFURCATION ANEURYSM. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 11.8MM, DOME 9.6MM, MAXIMUM ANEURYSM DIAMETER 9.6MM, NECK SIZE 5.0MM, AND DOME-TO-NECK RATIO 1.9MM. PARENT VESSEL DIAMETER WAS 2.0MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 8CM GALAXY G3 XSFT (GLX120308/L13627), ONE 3.5MM X 9CM GALAXY G3 XSFT (GLX123509/L12045), ONE 4MM X 8CM GALAXY G3 XSFT (GLX120408/L13272), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/L13817), ONE 5MM X 10CM GALAXY G3 (GLY120510/L13038), ONE 6MM X 11.9CM MICRUSFRAME10 (MFR100611/L15887), ONE 6MM X 26CM MICRUSFRAME10 (MFR100626/L15266), ONE 9MM X 22CM MICRUSFRAME14 (MFR140922/L15601), ONE 2MM X 6CM GALAXY G3 XSFT HEL (GLX120206/L11700), AND ONE 2MM X 8CM GALAXY G3 XSFT HEL (GLX120208/L13763) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. 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 20%. THE IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS II (RESIDUAL NECK). THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS OR STUDY DEVICE DEFICIENCIES. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON 21-SEP-2019 WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 0. MAGNETIC RESONANCE ANGIOGRAPHY (MRA) PERFORMED AT THE 180-DAY FOLLOW-UP VISIT ON 07-MAY-2020 DEMONSTRATED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB (RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL). MRS SCORE WAS 0. THE PATIENT SUBSEQUENTLY UNDERWENT RETREATMENT OF THE TARGET ANEURYSM ON 09-JUN-2020 WITH COIL EMBOLIZATION DUE TO RESIDUAL ANEURYSM. MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS IIIA (RESIDUAL ANEURYSM WITH CONTRAST WITHIN COIL INTERSTICES) FOLLOWING RETREATMENT. THERE WAS NO INTRAOPERATIVE ANEURYSM RUPTURE OR THROMBOEMBOLIC EVENT. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON 11-JUN-2020. THE PATIENT WAS STARTED ON PROPHYLACTIC ASAFLOW 80MG ON 20-SEP-2019 AND IS ONGOING.ADDITIONAL EVENT INFORMATION RECEIVED ON 30-JUN-2020 INDICATED THAT THE PHYSICIAN BELIEVES THAT COIL COMPACTION AND THE WIDE NECK OF THE ANEURYSM MAY HAVE CONTRIBUTED TO THE RECANALIZATION. THE COILS REMAINED WITHIN THE ANEURYSM SAC. THE PATIENT WAS NOT SYMPTOMATIC AS A RESULT OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702331 GALAXY G3 XSFT 4MM X 8CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLX120408 L13272 10886704077732

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| R