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

Model Number	7110-0206-3D
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	08/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The coil remains implanted and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause is unknown.The instructions for use (ifu) identifies thrombus as potential complications associated with use of the device.
Event or Problem Description
It was reported that an embolization coil was implanted in a ruptured basilar apex aneurysm on (b)(6) 2018.Approximately 13 days later, a straight, tail-like segment of the coil came out of the aneurysm into the proximal right posterior cerebral artery.A clot was noted around the tail segment, and a thalamic stroke was observed.Aspirin and heparin were administered to the patient as treatment for the clot.A cerebral angiography showed no evidence of thromboembolic complications.The clot appears to have resolved and there are no stroke symptoms.The patient is reported to be recovering well.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7840080
• Report Number: 2032493-2018-00179
• Device Sequence Number: 16441159
• Product Code: HCG
• UDI-Device Identifier: 00816777025395
• UDI-Public: (01)00816777025395(11)170919(17)220831(10)1709191WK
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2018

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: 08/31/2022
• Device Model Number: 7110-0206-3D
• Device Lot Number: 1709191WK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/31/2018
• 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
• Patient Age: 48 YR
• Patient Weight: 86