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

Model Number FG15090-040

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

Patient Problems Aneurysm (1708); Hemorrhage/Bleeding (1888)

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 implanted in the patient.Additionally, procedural and post procedural images were not provided; therefore, the reported event cannot be confirmed.

Event Description

It was reported through a literature article titled "delayed rebleeding of an acom aneurysm treated with a web device: endovascular management" that 24 months post complete occlusion of a cerebral aneurysm with a web sl, the aneurysm re-ruptured.The patient was reported to have recurrent aneurysmal bleeding.Balloon and stent-assisted coiling were performed, which completely occluded the recurrence.The patient suffered neither neurological deficit nor delayed complication.

• 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 ; 7142478000
• MDR Report Key: 11925999
• MDR Text Key: 256278539
• Report Number: 2032493-2021-00213
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00851566003901
• UDI-Public: (01)00851566003901(11)170530(17)200630(10)17053002
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: FG15090-040
• Device Lot Number: 17053002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2017
• 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