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

Model Number	7110-0254-3D-A2
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.One procedure image was provided for review, which demonstrates a coil mass within an aneurysm; however, the image is of poor quality and no other information can be ascertained.The delivery pusher was returned for evaluation.Visual inspection revealed burn marks on the heater coil, indicating the device was activated with a detachment controller, and a tensile break at the monofilament indicated excessive force was applied to the device, causing the coil to detach from the delivery pusher.The implant coil was not returned; therefore, the conditions or circumstances that led to the detachment could not be confirmed.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 stent-assisted coil embolization of an anterior communicating artery (acom) aneurysm, the embolization coil stretched in the aneurysm and then detached.The microcatheter was removed and a stretched segment of the coil remains in the parent artery.No additional intervention was performed.There was no reported patient injury.The patient was reported to be doing well.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10980793
• Report Number: 2032493-2020-00364
• Device Sequence Number: 703069
• Product Code: HCG
• UDI-Device Identifier: 00816777025425
• UDI-Public: (01)00816777025425(11)190513(17)240430(10)1905131W6
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K131948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2024
• Device Model Number: 7110-0254-3D-A2
• Device Lot Number: 1905131W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1