MAUDE Adverse Event Report: SEQUENT MEDICAL, INC. WEB LOW PROFILE SL-USA W4-7-3FOR US; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number FGA25070-030

Device Problems Separation Failure (2547); Malposition of Device (2616)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 06/29/2020

Event Type  Injury  

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 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
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): SEQUENT MEDICAL, INC.; 11 a columbia; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10341030
• MDR Text Key: 200962668
• Report Number: 2032493-2020-00185
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00854111006136
• UDI-Public: (01)00854111006136(11)170329(17)220228(10)17032904M
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR