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

Model Number	FGA25050-001
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Cerebral (1889); Rupture (2208)
Date of Event	10/10/2019
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 has not been returned to the manufacturer.The root cause of the complaint cannot be determined.However, tortuous vasculature and angle alignment was reported.The instructions for use (ifu) identifies aneurysm perforation or rupture, hemorrhage, vessel dissection or perforation, and death as potential complications associated with use of the device.This device is associated with the same procedure as reported in mfr report # 2032493-2019-00261.
Event or Problem Description
It was reported that treatment was performed for an unruptured anterior communicating artery aneurysm.The vessel was reported to be tortuous.An attempt was made to retract the web device into the via microcatheter for repositioning in the aneurysm.Additional force was required to recapture the web into the via due to the vessel tortuosity and the angle of the microcatheter in relation to the proximal marker of the web device.At the time the web was withdrawn into the via, the via "jumped" forward.The microcatheter was pulled back and an angiography run demonstrated contrast extravasation from the aneurysm.Heparin was reversed and protamine was administered.The via and web were removed together, a new microcatheter was placed, and three (3) embolization coils were implanted in the aneurysm, which stopped the bleeding; however, the patient developed intracranial hypertension during the procedure, and both pupils were noted to be dilated and unresponsive.An external ventricular drain (evd) was placed and the patient was admitted to the icu.The patient never regained consciousness and died four days later.The cause of death was determined by the physician to be "high intracranial pressure with central herniation.".

• Brand Name: WEB LOW PROFILE SLS-USA W4-5-SFOR 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: 9298617
• Report Number: 2032493-2019-00262
• Device Sequence Number: 2373665
• Product Code: OPR
• UDI-Device Identifier: 00854111006013
• UDI-Public: (01)00854111006013(11)190503(17)240610(10)19050370
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P170023
• 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): 10/10/2019

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/10/2024
• Device Model Number: FGA25050-001
• Device Catalogue Number: FGA25050-001
• Device Lot Number: 19050370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIA 21 MICROCATHETER
• Outcome Attributed to Adverse Event: Death; Hospitalization; Life Threatening; Required Intervention