MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT-3D-AV; NEUROVASCULAR EMBOLIZATION COIL

Model Number	7110-0306-3D-A2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Visual Impairment (2138); Thrombosis/Thrombus (4440)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
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.Imaging was not provided.The event as described could not be confirmed.
Event or Problem Description
It was reported through the rage clinical study that a ruptured right m2 saccular aneurysm was treated with an embolization implant coil.When the patient returned to the nsicu, they were found to have new onset left hemiplegia and gaze preference.An urgent ncct did not show re-bleeding.Patient sent for dsa to assess large vessel occlusion.Mechanical thrombectomy was then performed on thrombus at r proximal m2.The outcome was resolved without sequelae.

• Brand Name: HYDROSOFT-3D-AV
• Common Device Name: NEUROVASCULAR EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92868
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19379063
• Report Number: 2032493-2024-00408
• Device Sequence Number: 15373150
• Product Code: HCG
• UDI-Device Identifier: 00816777025463
• UDI-Public: (01)00816777025463(11)200831(17)250731(10)2008311W6
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/23/2024

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: 07/31/2025
• Device Model Number: 7110-0306-3D-A2
• Device Lot Number: 2008311W6
• 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: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• 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: HHYDROSOFT 3D IMPLANT COIL - 1907091W6
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female