MAUDE Adverse Event Report: SEQUENT MEDICAL, INC WEB LOW PROFILE SL-USA W4-6-5FOR US; WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM, PRODUCT

Model Number	FGA25060-050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to the manufacturer; therefore, an analysis could not be performed.The root cause cannot be determined.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 instructions for use (ifu) identifies rupture as a potential complication associated with the use of this device.The device associated with this event was used during the same procedure referenced in mfr.Report # 2032493-2019-00226.
Event or Problem Description
It was reported that during treatment of a middle cerebral artery aneurysm, the microcatheter ruptured the dome of the aneurysm.A web device was being advanced through the microcatheter at the time.The patient was treated with balloon remodeling and six embolization coils.After extubation, the patient was reported to have no cognitive impairment and was moving both sides of the body.

• Brand Name: WEB LOW PROFILE SL-USA W4-6-5FOR US
• Common Device Name: WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM, PRODUCT
• Manufacturer (Section D): SEQUENT MEDICAL, INC; 11 a columbia; aliso viejo CA 92656
• MDR Report Key: 9091608
• Report Number: 2032493-2019-00228
• Device Sequence Number: 2425196
• Product Code: OPR
• UDI-Device Identifier: 00854111006112
• UDI-Public: (01)00854111006112(11)190329(17)220417(10)19032908
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 08/20/2019

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: 04/17/2022
• Device Model Number: FGA25060-050
• Device Catalogue Number: FGA25060-050
• Device Lot Number: 19032908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/19/2019
• 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: Life Threatening; Required Intervention