MAUDE Adverse Event Report: MICROVENTION INC. HYDROFRAME-18-AV; DEVICE VASCULAR PROMOTING EMBOLIZATION

Model Number	7118-0827-A2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a rage clinical study, the patient had a mild compaction with remnant neck post procedure.The aneurysm location was posterior communication (pcom) on the left side.The height is 7.8mm, width 8.3mm, depth 7.7 mm, neck size 5.0 mm and dome to neck ratio: 1.66 mm.The patient underwent retreatment with using a flow diverter.The patient had a follow-up visit on (b)(6) 2022.There were no additional adverse events reported.Mrs score was 0.Patient exited the study on (b)(6) 2023.
Additional Manufacturer Narrative
A search for non-conformances associated with this 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 not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The alleged product issue/event as described could not be confirmed.

• Brand Name: HYDROFRAME-18-AV
• Common Device Name: DEVICE VASCULAR PROMOTING EMBOLIZATION
• 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: 20647746
• Report Number: 2032493-2024-00820
• Device Sequence Number: 7470897
• Product Code: KRD
• UDI-Device Identifier: 00816777023940
• UDI-Public: (01)00816777023940(11)190213(17)240131(10)1902131W7
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K132952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2024

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: 01/31/2024
• Device Model Number: 7118-0827-A2
• Device Lot Number: 1902131W7
• 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: 10/18/2024
• Initial Report FDA Received Date: 11/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female