MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 4MM X 11.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR100412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 k10459 number, and no non-conformances related to the malfunction were identified.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 is one of four products involved with the complaint and the associated manufacturer report numbers are: 3008114965-2021-00670, 3008114965-2021-00672, and 3008114965-2021-00673.
Event or Problem Description
As reported by the (b)(6) 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.
Additional 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 (b)(6) 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: MICRUSFRAME10 4MM X 11.5CM
• Common Device Name: 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: 13010248
• Report Number: 3008114965-2021-00671
• Device Sequence Number: 11993551
• Product Code: KRD
• UDI-Device Identifier: 10886704077817
• UDI-Public: 10886704077817
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: MFR100412
• Device Catalogue Number: MFR100412
• Device Lot Number: K10459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON 10 MICROCATHETER (MEDTRONIC); GALAXY G3 XSFT 2.5MM X 5CM; GALAXY G3 XSFT 2MM X 2CM; GALAXY G3 XSFT HEL 2MM X 6CM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White