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

Model Number W4-6-3-MVI-3

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

Patient Problem Ruptured Aneurysm (4436)

Event Date 08/04/2021

Event Type  Injury  

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 remains implanted in the patient and procedure images were not provided; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies aneurysm perforation or rupture and hemorrhage as potential complications associated with use of the device.

Event Description

It was reported that the web device was used for the treatment of a right middle cerebral artery (mca) aneurysm with a daughter sac.Reportedly, the aneurysm ruptured upon web deployment and immediately protamine was administered and a balloon utilized to arrest bleeding.Physician commented that the daughter sac is a weak area of the aneurysm.Patient had a head ct scan after the intervention and it demonstrated intra-cranial bleeding.The patient remained stable with no drop in their vitals.Bp remained 100 during the entire procedure.

• Brand Name: WEB SLS
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12410551
• MDR Text Key: 269456405
• Report Number: 2032493-2021-00356
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102190
• UDI-Public: (01)00842429102190(11)201029(17)250930(10)2010291AA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• 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: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: W4-6-3-MVI-3
• Device Lot Number: 20111712A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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): Required Intervention
• Patient Age: 73 YR