MAUDE Adverse Event Report: SEQUENT MEDICAL, INC WEB LOW PROFILE SL; WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM

Model Number	FGA25050-030
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Rupture (2208); Vascular System (Circulation), Impaired (2572)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device remains implanted; therefore, a product analysis could not be performed.The root cause is unknown.
Event or Problem Description
It was reported that treatment was being performed for an unruptured middle cerebral artery aneurysm.Access to the treatment site and positioning of the web in the aneurysm were accomplished without incident.After placement of the web, there was difficulty maintaining the patient's airway, and it appeared that the left lung had collapsed.The web was detached, and follow-up angiography confirmed proper placement.No contrast extravasation was noted at that time.The procedure was paused for several minutes to manage the patient's airway.Upon resuming the procedure, angiography demonstrated contrast extravasation from the aneurysm.A scepter occlusion balloon was placed and inflated at the neck of the aneurysm for approximately 3 minutes, occluding the aneurysm.During deflation of the balloon, it appeared that the web shifted position, occluding two mca m2 divisions; therefore, an atlas stent was implanted across the neck of the aneurysm to secure the web in the aneurysm to allow the mca branches to remain patent.The procedure was completed with satisfactory placement of the web and no evidence of active extravasation.Post-procedure mra was performed immediately after the procedure, which demonstrated small focal deficits in the frontal lobe and blood in the subarachnoid space.The patient was moved to the icu, awoke, was extubated, and was able to move all limbs.For two days following the procedure, patient status follow-ups from the physician indicated the patient was recovering and still in the icu.The peri-procedural hemorrhage was determined to be a procedure-related incident from the anesthesia related complications.Post-procedure, the patient had a full neurological recovery almost to baseline.Prior to discharge, the patient expired from acute liver and kidney failure due to her previous medical condition.

• Brand Name: WEB LOW PROFILE SL
• 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: 8462772
• Report Number: 2032493-2019-00069
• Device Sequence Number: 16551285
• Product Code: OPR
• UDI-Device Identifier: 00854111006068
• UDI-Public: (01)00854111006068(11)181221(17)220118(10)18122102
• 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): 02/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2022
• Device Model Number: FGA25050-030
• Device Catalogue Number: FGA25050-030
• Device Lot Number: 18122102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/28/2019
• 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: Death; Hospitalization; Other; Required Intervention
• Patient Age: 69 YR