MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR DEVICES

Model Number W2-9-7-MVI

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.The instructions for use (ifu) identifies non detachment as potential complications associated with use of the device.Potential complications as referenced on the ifu, include but are not limited to the following: hematoma at the site of entry, aneurysm rupture, emboli, vessel perforation, parent artery occlusion, hemorrhage, ischemia, vasospasm, clot formation, device migration or misplacement, premature or difficult device detachment, non-detachment, incomplete aneurysm filling, revascularization, post-embolization syndrome, and neurological deficits including stroke and death.

Event Description

It was reported that during the embolization of the left middle cerebral artery aneurysm, the web device was unable to detach using the detachment controller.A new web device and catheter were used to deploy a web device successfully.No patient harm or injury was reported.The patient outcome was reported to be good.

Manufacturer Narrative

Items returned for evaluation: elivery system (pusher) web implant.Introducer.Dispenser hoop.Via 27 microcatheter.Items not returned for evaluation: controller.The web implant was returned still attached to the pusher for analysis and was returned within the introducer.Upon inspection of returned items, the web implant was found to be within visual and dimensional specifications (spec: diameter(mm)= 9.0 0.9, height(mm)= 7.0 0.7), but the proximal connector was kinked at the brown lead wire joint, and the pusher exhibited kinks at the hypotube to connector junction and at the proximal end of the hypotube.Tested the returned device with an in-house controller and gave red lights.The delivery system resistance was measured to be ol (spec= 66-78), which is out of specification due to the connector damage.The heater coil section was dissected to investigate any obstruction that could possibly prevent the implant from detaching, but the heater coil did was not found to be stretched and did not show signs of activation using a detachment controller.Investigation of the returned via 27 microcatheter found the device kinked at 4cm and 2cm from the distal tip; furthermore, a 0.027" od test mandrel did experience resistance at the distal end during advancement due to the kinked areas.The investigation of the returned web system found the proximal connector and hypotube sections of the delivery system to be kinked.The unit did not pass continuity and resistance testing during the investigation due to the kinked proximal connector, which is consistent with the reported non-detachment.The returned via 27 microcatheter was found kinked at 4cm and 2cm from the distal tip; furthermore, a test mandrel experienced resistance at the distal end of the microcatheter during advancement testing due to the kinked areas, which is consistent with the reported deployment issue.The physical evaluation of the devices could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the devices experiencing forces over specification.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR DEVICES
• 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: 18692064
• MDR Text Key: 335304475
• Report Number: 2032493-2024-00121
• Device Sequence Number: 1
• Product Code: OPR
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W2-9-7-MVI
• Device Lot Number: 0000262956
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other