MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number FGA15080-040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Eye Pain (4467)

Event Date 03/01/2021

Event Type  Death  

Manufacturer Narrative

A search for non-conformances associated with the reported 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 implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies death and hemorrhage as potential complications associated with use of the device.

Event Description

It was reported that a web device was implanted in a ruptured aneurysm of the left internal carotid artery bifurcation on (b)(6) 2020 with good occlusion of the aneurysm and stagnate flow in the sac.The patient was evaluated one month post-op and the aneurysm did not show up on mra.The aneurysm was determined to be occluded.At three months post-op, the patient developed eye pain.Imaging revealed the aneurysm had grown significantly, the aneurysm appeared to have significant filling in the neck and base of the aneurysm sac, and the web was compacted into the dome.The patient experienced acute symptoms was diagnosed with a large subdural hematoma and subarachnoid hemorrhage.The patient later passed away.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 11853150
• MDR Text Key: 251638195
• Report Number: 2032493-2021-00177
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00856956005817
• UDI-Public: (01)00856956005817(11)200304(17)250228(10)20030411C
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162524
• 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: 05/18/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: FGA15080-040
• Device Catalogue Number: FGA15080-040
• Device Lot Number: 20030411C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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): Death
• Patient Age: 73 YR