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

Model Number W5-4.5-2

Device Problem Separation Failure (2547)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

It was reported that during a web embolization procedure to treat the basilar tip aneurysm and left posterior communicating artery(p-com) with a prior sah condition, the web would not detach.The basilar tip had likely ruptured, and the left p-com likely had unruptured.The patient was treated with a bigger web sl.The physician stated that the web was not related to the patient¿s complication.The patient¿s status was reported as post sah, the score was gcs=15.

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 stated to be available for return to the manufacturer for evaluation, but has not yet been returned.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr 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.

Manufacturer Narrative

The investigation of the returned web system found the proximal connector kinked at the brown lead wire joint.The heater coil pet and implant tether were found melted, indicating that the device was activated using a detachment controller during the procedure; however, the device failed continuity and resistance testing during the investigation due to the damaged connector, which is consistent with the alleged detachment issue.The investigation of the returned device did not find any other damage or anomaly that would have caused or contributed to the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the proximal connector damage, but the damage is consistent with the device experiencing forces over specification.

Event Description

See h10.

• 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: 18956648
• MDR Text Key: 338738150
• Report Number: 2032493-2024-00237
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102053
• UDI-Public: (01)00842429102053(11)230906(17)280831(10)0000416816
• 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: 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-4.5-2
• Device Lot Number: 0000416816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2023
• 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 Sex: Female