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

Model Number	7110-0308
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Thrombus (2101)
Date of Event	07/16/2018
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 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, vascular occlusion, and ischemia as potential complications associated with use of the device.
Event or Problem Description
It was reported that during a balloon assisted treatment of a right side posterior communicating artery aneurysm, the 2nd embolization coil became unresponsive to the physician's movement.The coil was noted to have stretched, as seen on an angiogram.The stretched coil was intentionally detached with the controller in the microcather.The coil was successfully retrieved with two (2) separate snare devices and the patient was reported to have excellent blood flow past the aneurysm; however, clotting and vasospasm occurred during the extended time it took to remove the coil (4 hours).Reopro was administered to treat the clot, and verapamil was used for the vasospasm.During follow-up the day after the procedure, it was reported that the patient had a small stroke, but is okay, alert, and talking.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7783110
• Report Number: 2032493-2018-00164
• Device Sequence Number: 19085576
• Product Code: HCG
• UDI-Device Identifier: 00816777025470
• UDI-Public: (01)00816777025470(11)171017(17)220930(10)1710171W9
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/16/2018

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?: No
• Operator of Device: Other
• Device Expiration Date: 09/30/2022
• Device Model Number: 7110-0308
• Device Lot Number: 1710171W9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/14/2018
• 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: 45 YR