MAUDE Adverse Event Report: SEQUENT MEDICAL, INC WEB LOW PROFILE SL-USA W4-7-5FOR US; WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM

Model Number	FGA25070-050
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Thrombus (2101)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
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.The device was not returned for evaluation; an analysis of the device could not be conducted.
Event or Problem Description
It was reported that treatment was performed for an anterior communicating (acomm) artery aneurysm.After placement of the web in the aneurysm, it was noted that there was a 30-40% protrusion into the a2 artery, but there was no flow restriction, so the web was detached.Within a couple of days post-procedure, the patient began having seizures.An mri was performed 3 days after the procedure, which demonstrated a clot and stroke in the left a2 artery.No clot had been visualized in the procedure angiograms.Dual antiplatelet therapy was administered, as well as a heparin drip.Currently, the patient is extubated but cannot move his right arm or leg.

• Brand Name: WEB LOW PROFILE SL-USA W4-7-5FOR 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: 8881484
• Report Number: 2032493-2019-00189
• Device Sequence Number: 2128692
• Product Code: OPR
• UDI-Device Identifier: 00854111006150
• UDI-Public: (01)00854111006150(11)181114(17)211206(10)18111420
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

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: 12/06/2021
• Device Model Number: FGA25070-050
• Device Catalogue Number: FGA25070-050
• Device Lot Number: 18111420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/09/2019
• 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: Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 73 YR