MAUDE Adverse Event Report: SEQUENT MEDICAL, INC WEB LOW PROFILE SL-USA W4-7-3FOR US; WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM, PRODUCT

Model Number	FGA25070-030
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Codes	Hemorrhage, Subarachnoid (1893); Rupture (2208)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 device was not returned for evaluation; therefore, an analysis could not be conducted.The root cause cannot be determined.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 # 2032493-2019-00223.
Event or Problem Description
It was reported that treatment was attempted on an anterior communicating artery aneurysm (acom) which had an acute takeoff angle from the parent artery.After multiple attempts, the microcatheter finally gained access to the aneurysm from the right internal carotid artery (ica); however, the web device was not opening adequately, despite several deployment attempts.The microcatheter and web device were removed.A new via 21 microcatheter was successful at obtaining access to the aneurysm from the left ica.Deployment of the same web device was attempted, but efforts were unsuccessful due to difficult anatomy.During partial deployment of the web, a new roadmap image was obtained, which demonstrated an aneurysm rupture with contrast extravasation.The web device was removed and the aneurysm was partially coiled through the via microcatheter, which was effective at controlling the bleeding; however, changes in the patient's vital signs were indicative of a subarachnoid hemorrhage.The aneurysm treatment was stopped at this point so that an evd could be placed.The patient was stable at the end of the procedure.The patient is reported to have recovered and the aneurysm was retreated with another endovascular procedure.

• Brand Name: WEB LOW PROFILE SL-USA W4-7-3FOR 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: 9056928
• Report Number: 2032493-2019-00222
• Device Sequence Number: 19609962
• Product Code: OPR
• UDI-Device Identifier: 00854111006136
• UDI-Public: (01)00854111006136(11)190123(17)220206(10)19012304
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/06/2022
• Device Model Number: FGA25070-030
• Device Catalogue Number: FGA25070-030
• Device Lot Number: 19012304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/14/2019
• 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: Required Intervention