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

Model Number W2-8-5-MVI

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Aneurysm (1708); Rupture (2208)

Event Date 05/20/2022

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 remains implanted in the patient; therefore, product evaluation could not be performed.The instructions for use (ifu) identifies aneurysm perforation or rupture, and death as potential complications associated with use of the device.

Event Description

It was reported that a web sl device was used in an embolization procedure to treat a patient with two acute aneurysms.A right posterior communicating (pcom) aneurysm to be treated with a web 27 system and a right middle cerebral artery (mca) aneurysm to be treated with a web 17 system.The pcom aneurysm was attempted first where the web 27 device was deployed and detached.Upon detachment, approximately 20% of the web protruded into the parent vessel.The decision was made to treat the right mca before dealing with the protrusion.As the via 17 microcatheter tracked beyond the protruding web, it caught onto the device and dragged the web into the parent vessel.Numerous attempts were made to retrieve the device but were unsuccessful.The vessel occluded and the right pcom re-ruptured, which was then treated with coiling.The vessel remained occluded and the patient suffered an infarct in the right mca territory.The patient decompensated and died 48 hours post procedure.No device was implanted in the mca.

• 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; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15020582
• MDR Text Key: 295947598
• Report Number: 2032493-2022-00263
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102350
• UDI-Public: (01)00842429102350(11)210125(17)251231(10)21012512X
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2022

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
• Device Operator: Health Professional
• Device Model Number: W2-8-5-MVI
• Device Lot Number: 21012512X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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
• Treatment: VIA 17 MICROCATHETER.
• Patient Outcome(s): Death