MAUDE Adverse Event Report: SEQUENT MEDICAL, INC. WEB LOW PROFILE SL-USA W4-5-3FOR US; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number	FGA25050-030
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Vascular System (Circulation), Impaired (2572)
Date of Event	07/16/2020
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.The instructions for use (ifu) identifies parent artery occlusion, vascular thrombosis, neurologic deficits, and device migration or misplacement as potential complications associated with use of the device.
Event or Problem Description
It was reported that after the web was implanted in an acom aneurysm, the device protruded into the parent artery approximately 40-50%; however, the a2 was filling nicely.After the patient woke up post-procedure, he had right sided weakness that worsened.The patient was brought back to the angio suite and angiography demonstrated clot on the web that extended into the a2.Tpa was delivered to the patient, which dissolved the clot.Final angiograms looked good.Post-operatively, the patient was placed on a heparin drip and prescribed aspirin and plavix.There was no sequela.

• Brand Name: WEB LOW PROFILE SL-USA W4-5-3FOR US
• Common Device Name: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): SEQUENT MEDICAL, INC.; 11 a columbia; aliso viejo, ca
• MDR Report Key: 10411630
• Report Number: 2032493-2020-00208
• Device Sequence Number: 2198846
• Product Code: OPR
• UDI-Device Identifier: 00854111006068
• UDI-Public: (01)00854111006068(11)200226(17)250131(10)20022612X
• 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): 07/17/2020

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: 01/31/2025
• Device Model Number: FGA25050-030
• Device Catalogue Number: FGA25050-030
• Device Lot Number: 20022612X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/14/2020
• 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