MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-10-AV; COILS

Model Number	7110-0515-A2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and is not available for return to the manufacturer for analysis and product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.The instructions for use (ifu) identifies aneurysm recanalization as potential complications associated with use of the device.
Event or Problem Description
As reported through the rage clinical study, event term: aneurysm recanalization event #: 1 event start date: 06/mar/2023 post operative days: 292 days event description : recanalization requiring retreatment.Asymptomatic.Ae outcome : resolved without sequelae event was reviewed by independent reviewer (cea) and was determined to be definitely related to study device and probably related to study procedure.The initial treatment date: (b)(6) 2023 initial treatment: midline anterior communicating artery retreatment performed, intrasacular device was placed on (b)(6) 2024.

• Brand Name: HYDROFRAME-10-AV
• Common Device Name: COILS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19316004
• Report Number: 2032493-2024-00382
• Device Sequence Number: 17722186
• Product Code: HCG
• UDI-Device Identifier: 00816777023681
• UDI-Public: (01)00816777023681(11)210825(17)260731(10)0000070865
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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: 07/31/2026
• Device Model Number: 7110-0515-A2
• Device Lot Number: 0000070865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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: HYDROSOFT 3D 1.5X4, LOT 0000107617; HYDROSOFT 3D 2X4, LOT 0000138844; HYDROSOFT 3D 3X4, LOT 2001311W6
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male