MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D ADVANCED; VASCULAR EMBOLIZATION DEVICE

Model Number	7110-0308-3D-A2
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Perforation of Vessels (2135)
Date of Event	02/26/2020
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 not returned to the manufacturer for evaluation.The root cause cannot be determined.The coil detachment occurred after the aneurysm perforation; therefore, the device malfunction did not cause or contribute to the adverse event.Additionally, it is unknown if the coil or the microcatheter (not a microvention device) perforated the aneurysm.
Event or Problem Description
It was reported that treatment was performed for a choroidal aneurysm.During placement of the embolization coil, the aneurysm was perforated.During the attempt to retract the coil, the coil stretched and then detached.Another coil was placed in the aneurysm, which was successful in stopping the extravasation.The detached coil segment was then removed from the patient with a stent retriever.The patient woke up from anesthesia.The patient was reported to have had a stroke, but was slowly improving.
Additional Manufacturer Narrative
Additional information received from the sales representative indicated that the patient presented to the hospital with a subarachnoid hemorrhage.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9892316
• Report Number: 2032493-2020-00075
• Device Sequence Number: 2909896
• Product Code: HCG
• UDI-Device Identifier: 00816777025470
• UDI-Public: (01)00816777025470(11)181119(17)231031(10)1811195W6
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: Other
• Device Expiration Date: 10/31/2023
• Device Model Number: 7110-0308-3D-A2
• Device Catalogue Number: 7110-0308
• Device Lot Number: 1811195W6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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; Life Threatening; Required Intervention