MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 ADVANCED; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	7110-0515-A2
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/03/2021
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 not returned to the manufacturer for evaluation.Therefore, the alleged product issue could not be confirmed.The instructions for use identifies clot formation as a potential complication associated with use of the device.
Event or Problem Description
It was reported that a patient enrolled in the rage study underwent treatment for a aneurysm of the right pcom.During the embolization, a coil implant began to stretch and was removed in its entirety with the microcatheter.Following this, there was clot seen in the m3 segment of the right mca branch.The clot was cleared with wire maceration.Additional heparin was given during the procedure.Following the procedure, the patient was neurologically intact.The outcome was reported as "resolved without sequelae" on (b)(6) 2021.

• Brand Name: HYDROFRAME 10 ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12028243
• Report Number: 2032493-2021-00239
• Device Sequence Number: 14299972
• Product Code: HCG
• UDI-Device Identifier: 00816777023681
• UDI-Public: (01)00816777023681(11)181002(17)230930(10)1810025WF
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 7110-0515-A2
• Device Lot Number: 1810025WF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention