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

Model Number	7110-0510-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	11/14/2020
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 not returned to the manufacturer for analysis.Intraprocedural or post-procedural images were not provided for review; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies stroke and premature coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that a ruptured aneurysm of anterior communicating artery was treated with an embolization coil implant.At the time of positioning the coil implant, the patient was noted to have a change in mental status, which was likely a seizure event.After sedation had been given in addition to seizure medication and patient refrained from actively moving, the physician wished to remove the coil and use a smaller one.The implant detached upon attempted retraction into the microcatheter.The physician left the coil in position and chose to end the procedure and transfer the patient to the intensive care unit given their "decline and neurologic status with recent seizure activity." follow-up angiography was performed, establishing that there was no filling of the aneurysm.It was noticed that the left anterior cerebral artery branch was not filling as it had previously, the cause or suspected cause of which was not stated by the physician.After the procedure, the patient had a stroke, the cause and location of which was not stated.It was related by a hospital employee that it may have been due a coil tail protruding into the parent artery or a piece of guidewire left behind, but the presence of a coil tail or fragment of a device was not mentioned in an operative report obtained from the hospital.The patient was hospitalized for 95 days and released to a care facility on (b)(6) 2021.The patient is said to be following commands and making improvements.

• Brand Name: HYDROFRAME 10 ADVANCED
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11606723
• Report Number: 2032493-2021-00108
• Device Sequence Number: 19835864
• Product Code: KRD
• UDI-Device Identifier: 00816777023674
• UDI-Public: (01)00816777023674(11)200427(17)250331(10)2004275PF
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/01/2021

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: 03/31/2025
• Device Model Number: 7110-0510-A2
• Device Lot Number: 2004275PF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 04/02/2021
• 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: Hospitalization; Disability
• Patient Age: 42 YR