BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY G3 XSFT 3.5MM X 7.5CM

    MDR report key: 17281255 · Received July 7, 2023

    Report

    Report Number
    3008114965-2023-00470
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    June 13, 2023
    Report Date
    January 16, 2025
    Manufacturer
    CERENOVUS, INC.
    Product Code
    KRD
    UDI-DI
    10886704077664
    PMA / PMN Number
    K150319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). SECTION B5: ADDITIONAL INFORMATION WAS RECEIVED ON 11-JUL-2023. SUMMARY OF INFORMATION PROVIDED: THE RETREATMENT OF THE TARGET ANEURYSM WAS TREATED WITH NON-CERENOVUS COILS (KANEKA). WAS CEREBASE USED AS A GUIDE SHEATH FOR THIS PROCEDURE WAS UPDATED TO "NO". WAS CERENOVUS/ CODMAN MICROCATHETER (PROWLER) USED FOR THE PROCEDURE? WAS CHANGED TO "NO". THE RESIDUAL ANEURYSM VALUE "YES" HAS BEEN CHANGED TO "NO" AND THE ANEURYSM INCREASE IN SIZE VALUE "NO" HAS BEEN CHANGED TO "YES". ADDITIONAL INFORMATION WAS RECEIVED ON 19-JUL-2023. SUMMARY OF INFORMATION PROVIDED: A FOLLOW-UP DIAGNOSTIC ANGIOGRAM DEMONSTRATED RECANALIZED/RECURRED NECK BASE OF ANEURYSM WITH INTERVAL GROWTH OF THE ANEURYSM COMPARED TO THE DIAGNOSTIC ANGIOGRAM ON (B)(6) 2022. THE PATIENT WAS NOT SYMPTOMATIC AS A RESULT OF RECANALIZATION. THE COILS REMAINED WITHIN THE ANEURYSM SAC. THERE WERE NO RESIDUAL SYMPTOMS. A 1.5 MM X 3 CC SILKY SOFT KANEKA COIL WAS USED DURING THE RETREATMENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 AFTER THE RETREATMENT. THE DEVICE REMAINS IMPLANTED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE K10383 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. ANEURYSM RECANALIZATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH COIL EMBOLIZATION PROCEDURES. THERE WERE NO ALLEGED QUALITY ISSUES REGARDING THE CERENOVUS GALAXY SERIES COILS THAT WERE USED DURING THE INITIAL PROCEDURE. THE DEVICES PERFORMED AS INTENDED AND IMMEDIATE POST-SURGICAL IMAGING CONFIRMED COMPLETE OBLITERATION. HOWEVER, IT CANNOT BE RULED OUT THAT THE CERENOVUS COILS PLAYED A ROLE IN THE RECURRENCE OF THE ANEURYSM WHICH REQUIRED SURGICAL INTERVENTION. THIS EVENT DOES MEET US FDA REPORTING CRITERIA UNDER 21 CFR 803 AS A ¿SERIOUS INJURY¿. 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 TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> PC-(B)(4). SECTION A1. PATIENT IDENTIFIER: MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS IS ONE OF FIVE PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2023-00469, 3008114965-2023-00470, 3008114965-2023-00472, 3008114965-2023-00473 AND 3008114965-2023-00474.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). SECTION B5: ADDITIONAL INFORMATION RECEIVED ON 31-JUL-2023. SUMMARY OF THE INFORMATION PROVIDED: THE ANEURYSM INCREASE IN SIZE VALUE "YES" HAS BEEN CHANGED TO "NO". "CLASS I: COMPLETE = COMPLETE OBLITERATION" HAS BEEN CHANGED TO "CLASS II: RESIDUAL NECK = PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL BUT WITHOUT OPACIFICATION OF THE ANEURYSMAL SAC". A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). SECTION B5: ADDITIONAL/MODIFIED INFORMATION WAS RECEIVED ON 18-DEC-2024. SUMMARY: THE OUTCOME FOR THE RETREATMENT PROCEDURE WAS UPDATED FROM "CLASS II: RESIDUAL NECK: PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL BUT WITHOUT OPACIFICATION OF THE ANEURYSMAL SAC" TO "CLASS I: COMPLETE: COMPLETE OBLITERATION." A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    AS REPORTED VIA THE STERLING STUDY (CNV_2017_01), A 51-YEAR-OLD FEMALE (SUBJECT 485-059) WITH A HISTORY OF CONTROLLED HYPERTENSION AND POLYCYSTIC KIDNEY DISEASE UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM IN THE BIFURCATION BRANCH OF THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) ON (B)(6) 2022. THE PATIENT¿S PRE-PROCEDURE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: HEIGHT 5.0 MM, DOME 4.7 MM, MAXIMUM ANEURYSM DIAMETER 5.1 MM, NECK SIZE 1.3 MM, AND DOME-TO-NECK RATIO OF 3.6 MM. THE PARENT VESSEL DIAMETER WAS 1.5 MM. COIL EMBOLIZATION WAS PERFORMED WITH FIVE (5) CERENOVUS COILS: A GALAXY G3 4MM X 7CM ((B)(4) ), A GALAXY G3 XSFT 3.5MM X 7.5CM ((B)(4) ), A GALAXY G3 XSFT 2MM X 2CM ((B)(4) ), A GALAXY G3 XSFT 2MM X 2CM ((B)(4) ) AND A GALAXY G3 XSFT 2MM X 2CM ((B)(4) ) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. A BALLOON CATHETER (BRAND NOT SPECIFIED) WAS ALSO USED, BUT NOT IMPLANTED. 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. ANGIOSUITE PACKING DENSITY WAS NOT MENTIONED IN THE CRF. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE OBLITERATION. THERE WERE NO REPORTED STUDY DEVICE DEFICIENCIES OR INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON 07-DEC-2022. THE PATIENT WAS SEEN ON (B)(6) 2023 FOR A 180-DAY FOLLOW-UP WITH A MODIFIED RANKIN SCALE SCORE WAS 0. ON (B)(6) 2023, THE PATIENT UNDERWENT DIGITAL SUBTRACTION ANGIOGRAM (DSA) IMAGING. THE RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS II: RESIDUAL NECK= PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ANTERIOR WALL BUT WITHOUT OPACIFICATION OF THE ANEURYSMAL SAC. THE PATIENT SUBSEQUENTLY UNDERWENT ANEURYSM RETREATMENT ON (B)(6) 2023 DUE TO A ¿RESIDUAL ANEURYSM¿ AND ¿RESIDUAL NECK¿. THE DEVICES USED FOR RETREATMENT WERE NOT ENTERED IN THE CRF AT THE TIME OF THIS REVIEW. THE PATIENT DID NOT EXPERIENCE ANY INTRA-OPERATIVE ANEURYSM RUPTURE OR THROMBOEMBOLIC EVENT. THE PATIENT¿S DISCHARGE INFORMATION HAS NOT BEEN ENTERED INTO CRF AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014581 GALAXY G3 XSFT 3.5MM X 7.5CM NEUROVASCULAR EMBOLIZATION DEVICE KRD CERENOVUS, INC. GLX123575 K10383 10886704077664

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention| L BALLOON CATHETER| EXCELSIOR SL-10 (STRYKER) MICROCATHETER| GALAXY G3 4 MM X 7 CM| GALAXY G3 XSFT 2 MM X 2 CM| GALAXY G3 XSFT 2 MM X 2 CM| GALAXY G3 XSFT 2 MM X 2 CM