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

Model Number	7110-0256-3D-A2
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
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 has been received by the manufacturer for evaluation.The investigation is currently ongoing.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during treatment of an acom aneurysm, the embolization coil was repositioned twice.During the 3rd attempt to withdraw the coil, the coil stretched and then detached, leaving a 5-6cm remnant in a portion of the a1 segment and the parent internal carotid artery.After an exchange of microcatheters, a stentriever was used to capture the entire detached coil segment from the patient.The aneurysm was successfully treated with subsequent coils.There was no reported patient injury.The patient is currently reported to be stable and doing well post-procedure.
Additional Manufacturer Narrative
The delivery pusher, implant coil, and a 4mm x 20cm trevo stentriever (stryker device) were received for evaluation.The pusher was undamaged and met specifications.The pusher's most distal section did not have any damage.The implant coil was returned separated from the pusher and seveley stretched, and the attachment monofilament was broken.The stretched implant coil was entangled with the 4mm x 20cm trevo stentriever (stryker) that was returned for investigation.The monofilament at the pusher section displayed a tail shape, a sign that the monofilament was stretched.The monofilament profile from within the pusher had a tail-like profile, which is consistent with the implant separating due to tensile force rather than activation using a detachment controller.The physical evaluation of the device alone could not determine the conditions or circumstances that led to the separation.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10176114
• Report Number: 2032493-2020-00135
• Device Sequence Number: 17022807
• Product Code: HCG
• UDI-Device Identifier: 00816777025432
• UDI-Public: (01)00816777025432(11)180418(17)230331(10)1804181W9
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070656
• 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): 05/21/2020

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 7110-0256-3D-A2
• Device Catalogue Number: 7110-0256
• Device Lot Number: 1804181W9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/03/2020
• 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: Required Intervention