MAUDE Adverse Event Report: SEQUENT MEDICAL, INC VIA-21 MICROCATHETER-US VIA-21-154-01FOR US

Model Number	FGA21154-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Extravasation (1842); Hemorrhage, Cerebral (1889); Thrombus (2101); Rupture (2208)
Date of Event	10/01/2019
Type of Reportable Event	Death
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 not returned to the manufacturer.The root cause of the event cannot be determined.However, the reported clinical information indicates there was no malfunction or issue with the microvention device.The instructions for use (ifu) identifies aneurysm rupture, vessel perforation, hemorrhage, vascular thrombosis, and death as potential complications associated with use of the device.
Event or Problem Description
It was reported that treatment was performed on a patient with ruptured aneurysms and a dual hemorrhagic stroke involving the distal anterior cerebral artery (aca) and the posterior communicating artery (pcom) on the same side.After successful implantation of two web devices and stasis of both aneurysms, the final angiography run demonstrated clot forming on the intermediate catheter (non-mv device) and the via microcatheter in the a2 artery.The via was removed, and aspiration and mechanical thrombectomy were performed.Extravasation was then noticed in the internal carotid artery and pcom origin.The web in the pcom aneurysm appeared to be intact with no visible deformations.A balloon was inflated at the site of extravasation, which reduced the bleeding.The patient was admitted to the icu.It was reported that the patient died approximately one week post-procedure; however, the cause and exact date of the patient's death are unknown.The physician did not consider there to have been a malfunction or issue with a microvention device.
Additional Manufacturer Narrative
Additional information provided to the manufacturer: the date of the patient's death is (b)(6) 2019.The documented cause of death on the death certificate is cardiopulmonary arrest secondary to aneurysmal subarachnoid hemorrhage due to cerebral aneurysm.

• Brand Name: VIA-21 MICROCATHETER-US VIA-21-154-01FOR US
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): SEQUENT MEDICAL, INC; 11 a columbia; aliso viejo CA 92656
• MDR Report Key: 9264704
• Report Number: 2032493-2019-00254
• Device Sequence Number: 11232655
• Product Code: DQY
• UDI-Device Identifier: 00851566003918
• UDI-Public: (01)00851566003918(11)190513(17)200630(10)19051304
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150894
• 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): 10/01/2019

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: 06/30/2020
• Device Model Number: FGA21154-01
• Device Catalogue Number: FGA21154-01
• Device Lot Number: 19051304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 11/28/2019
• 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; Hospitalization; Life Threatening; Required Intervention