MAUDE Adverse Event Report: SEQUENT MEDICAL, INC. WEB LOW PROFILE SL-USA W4-7-3FOR US; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number	FGA25070-030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/22/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
A search for non-conformances 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 web was implanted and the delivery system was not returned for evaluation.Several angiographic images obtained during the web implantation procedure were provided.The images are consistent with the reported complaint details; however, images were not provided of the aneurysm re-rupture that occurred several days post-procedure.The root cause for the event could not be determined.
Event or Problem Description
It was reported that the patient was admitted to the hospital on (b)(6) 2020 with a subarachnoid hemorrhage (sah) and treatment was performed the same day for a ruptured basilar tip aneurysm.The web device was placed and a small "encroachment" was noted.Flow in the vessel became limited; therefore, a stent (not a microvention device) was implanted at the neck of the aneurysm without incident.There was no active bleeding after treatment of the aneurysm with the web at the end of the procedure.The patient was placed on aspirin and plavix.The patient was admitted to the icu and three (3) days post-procedure on (b)(6) 2020 the aneurysm ruptured again.The patient died on (b)(6) 2020.

• Brand Name: WEB LOW PROFILE SL-USA W4-7-3FOR US
• Common Device Name: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): SEQUENT MEDICAL, INC.; 11 a columbia; aliso viejo, ca
• MDR Report Key: 10405738
• Report Number: 2032493-2020-00205
• Device Sequence Number: 11344732
• Product Code: OPR
• UDI-Device Identifier: 00854111006136
• UDI-Public: (01)00854111006136(11)190912(17)240831(10)19091211
• Combination Product (Y/N): N
• 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): 07/16/2020

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: 08/31/2024
• Device Model Number: FGA25070-030
• Device Catalogue Number: FGA25070-030
• Device Lot Number: 19091211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/13/2020
• 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: Death; Required Intervention
• Patient Age: 61 YR