MAUDE Adverse Event Report: SEQUENT MEDICAL, INC WEB LOW PROFILE SL-USA W4-5-3FOR US; WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM

Model Number	FGA25050-030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Subarachnoid (1893); Rupture (2208)
Date of Event	05/21/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The lot number was provided.The manufacturing records were reviewed.All inspection values were within specification and there were no ncr's or deviations.A lot history trending review was performed and there were no similar complaints for this lot number.The device was not returned for evaluation; however, there was no reported device malfunction.
Event or Problem Description
It was reported that the patient was being treated for an anterior communicating artery aneurysm.The microcatheter was advanced to the treatment site and the web was partially deployed within the aneurysm.The physician was not satisfied with the way the web was sitting, so the web was resheathed and an attempt was made to reposition it in the aneurysm.At that time, it was observed that the patient's blood pressure had spiked.A contrast injection demonstrated the aneurysm had ruptured.A balloon catheter was used to stop the bleeding.Multiple coils (non-microvention) were subsequently placed in the aneurysm and an evd was placed.Bleeding was controlled and the patient was taken to the icu post-op.It was later reported that the patient had expired three (3) days post-procedure.Subarachnoid hemorrhage was noted to be the cause of death.The physician stated there was no malfunction of the web device.

• Brand Name: WEB LOW PROFILE SL-USA W4-5-3FOR 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: 8719259
• Report Number: 2032493-2019-00158
• Device Sequence Number: 19450969
• Product Code: OPR
• UDI-Device Identifier: 00854111006068
• UDI-Public: (01)00854111006068(11)190304(17)220327(10)19030420
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• 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
• Report Date (Section B): 05/21/2019

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: 04/22/2022
• Device Model Number: FGA25050-030
• Device Catalogue Number: FGA25050-030
• Device Lot Number: 19030420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/20/2019
• 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; Life Threatening; Required Intervention
• Patient Age: 59 YR