MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFILL 10 ADVANCED; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	7310-1230-A2
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance 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 was implanted in the patient and not returned to the manufacturer for evaluation; therefore, the reported device issue could not be confirmed.The instructions for use (ifu) identifies premature detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that a embolization coil implant was approximately 60% deployed in an aneurysm of the internal carotid artery terminus when it began to stretch.The physician attempted to withdraw the coil and the pusher wire detached.The microcatheter was removed and the stretched coil was left in the patient.The coil stretched down to the patient's groin.The patient was reported to be "ok." there was no reported intervention or injury to the patient.

• Brand Name: HYDROFILL 10 ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11713556
• Report Number: 2032493-2021-00150
• Device Sequence Number: 3591016
• Product Code: HCG
• UDI-Device Identifier: 00816777023469
• UDI-Public: (01)00816777023469(11)200316(17)250228(10)2003161W5
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113457
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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: 02/28/2025
• Device Model Number: 7310-1230-A2
• Device Lot Number: 2003161W5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/23/2021
• 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: Other
• Patient Age: 71 YR