MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 2.5MM X 5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLX122505

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) patient identifier: (b)(6).The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30550293 number, and no non-conformances related to the malfunction were identified.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This is one of four products involved with the complaint and the associated manufacturer report numbers are 3008114965-2021-00670, 3008114965-2021-00671, 3008114965-2021-00672.

Event Description

As reported by the sterling study, a (b)(6) female ((b)(6)) with a history of active smoking and intracranial aneurysm underwent coil embolization of an unruptured left posterior communicating artery aneurysm on (b)(6) 2021 and experienced intraoperative aneurysm perforation.Balloon occlusion was performed as intervention, and the event required prolonged hospitalization.The patient is recovering from the event.The event was classified as severe.Per the principal investigator (pi), the event was related to the study device.The event was considered serious.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: modified information on the clinical research form (crf) indicated the following: endovascular intervention value "no¿ was changed to ¿yes¿.Remodeling balloon was positioned and inflated to treat the aneurysm perforation.Medication complete/update concomitant medications log value "no¿ was changed to ¿yes¿.Protamine was administered to reverse the heparin.Discharge date value "" was changed to 26-nov-2021.Section h6: health effect - impact code: medication required.Additional information is pending as to whether the perforation was associated with the target aneurysm.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 XSFT 2.5MM X 5CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13010228
• MDR Text Key: 287916776
• Report Number: 3008114965-2021-00673
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077626
• UDI-Public: 10886704077626
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: GLX122505
• Device Catalogue Number: GLX122505
• Device Lot Number: 30550293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ECHELON 10 MICROCATHETER (MEDTRONIC); GALAXY G3 XSFT 2MM X 2CM; GALAXY G3 XSFT HEL 2MM X 6CM; MICRUSFRAME10 4MM X 11.5CM
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White