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

Model Number W4-6-3-CN

Device Problem Separation Failure (2547)

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

Event Date 03/04/2024

Event Type  malfunction  

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 returned to the manufacturer for analysis and the investigation ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.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 an embolization procedure for an unruptured aneurysm of the middle cerebral bifurcation, 5.9mm in diameter, 4.6mm in height, and 4.0mm in the neck, the vessel was tortuous, and the diameter of the carrier artery was about 2.0mm.The microcatheter was in place, the web was implanted, and the angiography showed that the effect was good.During the web detach, found it was not detached.Replaced the controller and attempted several times but failed to detach.The procedure was completed after replaced the web.The patient was reported to be fine.

Event Description

Please see section h10 for the device investigation results.

Manufacturer Narrative

Investigation conclusion: the investigation of the returned web system found the web implant still attached to the pusher within the introducer, in good shape, and within visual and dimensional specifications.The unit did not pass continuity and resistance testing.Further inspection of the pusher found the black lead wire broken at the distal solder joint, which is consistent with non-detachment.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• 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: 18997850
• MDR Text Key: 339227627
• Report Number: 2032493-2024-00250
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429113769
• UDI-Public: (01)00842429113769(11)211214(17)251130(10)0000135003
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W4-6-3-CN
• Device Lot Number: 0000135003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• 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
• Patient Age: 63 YR
• Patient Weight: 72 KG