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 Codes	Separation Failure (2547); Malposition of Device (2616)
Health Effect - Clinical Code	Vascular System (Circulation), Impaired (2572)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing records were reviewed.All inspection values were within specification and there were no ncr's or deviations.The web was implanted and the delivery system was not returned for evaluation.The root cause cannot be determined.
Event or Problem Description
It was reported that treatment was performed for an aneurysm at the basilar apex.After placement of the web in the aneurysm, the web would not detach.The microcatheter was advanced to assist in detachment; however, during the detachment, the web rotated and blocked approximately 75% of the posterior cerebral artery (pca).A stent was implanted without incident in the pca to successfully recanalize the vessel.There was no reported patient injury or clinical consequence.The patient is currently reported to be doing well.

• 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: 10341030
• Report Number: 2032493-2020-00185
• Device Sequence Number: 3748811
• Product Code: OPR
• UDI-Device Identifier: 00854111006136
• UDI-Public: (01)00854111006136(11)170329(17)220228(10)17032904M
• 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): 06/29/2020

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: FGA25070-030
• Device Catalogue Number: FGA25070-030
• Device Lot Number: 17032904M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/29/2020
• 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: Required Intervention
• Patient Age: 73 YR