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 Codes	Neurological Deficit/Dysfunction (1982); Rupture (2208); Vascular System (Circulation), Impaired (2572)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was not returned for evaluation, as it remains implanted in the patient; however, there was no reported device malfunction.
Event or Problem Description
It was reported that the web device was being used to treat an aneurysm that came off the anterior communicating artery (acom) at an approximate 45-degree angle.The a-1 was straight, but there was some proximal tortuosity.The web was advanced into the aneurysm and during deployment, it became apparent the aneurysm ruptured; however, the exact location of the rupture was unknown.The web was deployed in the a-1 to cause stasis and essentially acted as a balloon, eliminating flow to the rupture site.The web was resheathed and a subsequent contrast injection was performed to identify the rupture site, which was determined to be at the dome of the aneurysm at the shallowest part.The web was then advanced up to the neck of the aneurysm and deployed partially until the distal end was flowered and atraumatic, the entire system was moved forward until the web was in the aneurysm, and then it was completely deployed.The web partially impinged on both a-2s, one about 20% and one approximately 70%.No further intervention was performed.Following the procedure, the patient had some significant neurological deficits, but continued to improve every day.The patient currently is essentially "fine" with only some very minor neurological deficit and is preparing to leave the hospital.

• 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: 8702160
• Report Number: 2032493-2019-00154
• Device Sequence Number: 11274847
• Product Code: OPR
• UDI-Device Identifier: 00854111006044
• UDI-Public: (01)00854111006044(11)190320(17)220422(10)19032002
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

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: Health Professional
• Device Expiration Date: 04/22/2022
• Device Model Number: FGA25040-030
• Device Catalogue Number: FGA25040-030
• Device Lot Number: 19032002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/14/2019
• 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: Hospitalization; Life Threatening; Disability