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

Model Number	100208HFRM-V-3D-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	05/17/2021
Type of Reportable Event	Death
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 pusher of the device was returned for evaluation and the attachment monofilament profile had a mushroom shape, indicating that a thermal detachment had occurred during the procedure.There was no fault to the circuitry of the pusher, as it had passed resistance and continuity testing, and no short condition was present.The pusher was damaged in multiple location along its length.The conditions or circumstances that led to the damage found on the pusher could not be identified, but the damage is consistent with the device experiencing forces over specification.The instructions for use (ifu) identifies premature coil detachment and death as potential complications associated with use of the device.
Event or Problem Description
It was reported that mv coils were utilized to treat a seriously ill patient with a ruptured aneurysm of the anterior communicating artery.After successful placement of four coils, the surgeon reported difficulty in repositioning of the 5th embolization coil.The coil apparently detached during repositioning, could not be removed, and approximately 4cm of the coil was left in the ica and a1 segment of the aca.A stent was placed to affix the coil to the walls of the vessel.The patient was reported to have passed away the following day as a result of a re-bleed of the aneurysm.The neurosurgery team considered the surgery extremely high risk given the patient's pre-procedure condition, and reported that the death was not due to the challenges encountered in the procedure.

• Brand Name: HYDROSOFT 3D
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12029245
• Report Number: 2032493-2021-00230
• Device Sequence Number: 3388498
• Product Code: HCG
• UDI-Device Identifier: 00816777026521
• UDI-Public: (01)00816777026521(11)201208(17)251130(10)2012085W6
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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: 11/30/2025
• Device Model Number: 100208HFRM-V-3D-A2
• Device Catalogue Number: 100208HFRM-V
• Device Lot Number: 2012085W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• 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: Death; Required Intervention