MAUDE Adverse Event Report: SEQUENT MEDICAL, INC WEB LOW PROFILE SL-USA W4-4-3FOR US; WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM

Model Number	FGA25040-030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	01/04/2020
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.The root cause of the complaint cannot be determined.
Event or Problem Description
It was reported that treatment was performed for a ruptured anterior communicating artery (pericallosal) aneurysm.The patient had not been given anticoagulant medication before the procedure.A post-deployment angiogram demonstrated normal flow in the a-com artery; however, a clot was identified at the neck of the aneurysm and on the web device.A bolus of integrilin was administered and full flow was restored.There was no reported clinical sequela.

• Brand Name: WEB LOW PROFILE SL-USA W4-4-3FOR US
• Common Device Name: WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM
• Manufacturer (Section D): SEQUENT MEDICAL, INC; 11 a columbia; aliso viejo CA 92656
• MDR Report Key: 9662629
• Report Number: 2032493-2020-00020
• Device Sequence Number: 2536008
• Product Code: OPR
• UDI-Device Identifier: 00854111006044
• UDI-Public: (01)00854111006044(11)190819(17)240909(10)19081929
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2020

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?: No
• Operator of Device: Other
• Device Expiration Date: 09/09/2024
• Device Model Number: FGA25040-030
• Device Catalogue Number: FGA25040-030
• Device Lot Number: 19081929
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2020
• Initial Report FDA Received Date: 02/03/2020
• 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