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

Model Number FGA25050-030

Device Problems Difficult to Remove (1528); Separation Failure (2547); Device Dislodged or Dislocated (2923)

Patient Problems Neurological Deficit/Dysfunction (1982); Vascular System (Circulation), Impaired (2572)

Event Date 09/27/2019

Event Type  Injury  

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 ifu identifies ischemic stroke and device migration or misplacement as potential complications associated with use of the device.This device is associated with the same procedure as the device reported in mfr report # 2032493-2019-00251.The submission of this report or related information to the fda, and its release by the fda, does not reflect a conclusion by the party submitting this report to the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reported event.

Event Description

It was reported that the patient was treated for a subarachnoid hemorrhage of the right mca.The web device was positioned in the aneurysm through a via microcatheter.Three unsuccessful attempts were made to detach the web and on the 4th attempt, the web detached with slight advancement of the via.At the time of the detachment, there was a slight proximal movement of the web.Follow-up angiography and ct images showed slight rotation of the web and a slight flow delay in the m2.Attempts were made to reposition the web back into the aneurysm with the via; however, the web appeared to rotate more within the aneurysm and the m2 had greater delayed flow.The m2 appeared to be occluded approximately 90% and a wire could not be passed through it.Multiple attempts were made to snare the web without success, so the procedure was aborted.The patient awoke with left sided weakness of the upper and lower limbs and hemineglect.Post-operative ct imaging confirmed the patient had a stroke due to occlusion of the superior m2, and the position of the web was stable with no filling in the aneurysm.The web appeared to be protruding somewhat into the m2.Two days after the procedure, the patient was treated multiple times for vasospasm due to the (pre-existing) sah and the patient underwent a decompressive craniotomy.An evd was placed.Currently, the patient has had great improvement in the use of her leg and some improvement in her arm.

• Brand Name: WEB ANEURYSM EMBOLIZATION DEVICE
• Type of Device: WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM
• Manufacturer (Section D): SEQUENT MEDICAL, INC; 11 a columbia; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 9243350
• MDR Text Key: 164249765
• Report Number: 2032493-2019-00253
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00854111006068
• UDI-Public: (01)00854111006068(11)190529(17)240619(10)19052942
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FGA25050-030
• Device Catalogue Number: FGA25050-030
• Device Lot Number: 19052942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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): Hospitalization; Life Threatening; Required Intervention; Disability