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

Model Number W5-7-3-MVI-MDR

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 11/26/2023

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with the reported part and lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and is not available for return to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If additional information is received, a supplemental report will be submitted.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

Event Description

It was reported that the web sl device was being used for the treatment of an acom aneurysm.After deployment in the aneurysm, the web would not detach despite use of multiple detachment controllers.The physician advanced the microcatheter and mechanically detached the web.No report of harm or injury to the patient, who was doing well.

Manufacturer Narrative

Correction: the manufacturer awareness date is: december 19, 2023.

Manufacturer Narrative

Investigation findings: items returned for evaluation: delivery system (pusher); 2x wdc-2.Items not returned for evaluation: web implant; introducer; dispenser hoop; microcatheter.The visual analysis of the returned items found the web implant to be separated from the delivery system and the implant was not returned for evaluation; furthermore, the proximal connector was kinked at the brown lead wire joint.Tested the returned device with an in-house controller and the returned controllers and gave red lights.The delivery system resistance was measured to be out of specification due to the proximal connector damage.The heater coil section was dissected to investigate any obstruction that could possibly prevent the implant from detaching.The heater coil was not found to be stretched; however, it did exhibit signs of activation using a detachment controller as pet was burnt and the tether was melted.The returned controllers were evaluated and found to be functioning as normal.Board voltage and duration were found to be within specification.Medical review of received procedure notes: a detailed medical review of procedure notes dated 2023-12-19 was performed.Data review indicates that the patient received endovascular treatment for an aca aneurysm with a selected web sl 7x3 device.Web device was inserted on 2023-12-19.Upon deployment of the web device within the aneurysm, the web device detached after eight attempts and with a change of two controller units, which were utilized to complete the detachment of the web device.The event occurred during the performance of the procedure.Web deployment outcome was reported as aneurysm being completely occluded with the web device placed in the anatomically optimal position within the aneurysm.Based on the review and medical opinion of manager of post-market clinical safety, the web device was clinically inserted and placed in the anatomically optimal position within the aneurysm with an associated inability to detach which required multiple attempts to detach the device with the use of two separate wdc units which finally lead to device detachment.The relationship of the event to the device is possible and cannot be ruled out.No device malfunction was reported and/or no device malfunction was reported as associated with or contributing to the adverse event.Investigation conclusion: the returned detachment controllers were found to function as intended and would not have caused or contributed to the reported event.The investigation of the returned web system found the proximal connector kinked.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher damage, but the damage is consistent with the device experiencing forces over specification.The implant was not returned for evaluation to investigate for other potential contributing factors.The heater coil showed signs of activation using a detachment controller, and the evaluation did not identify any other condition with the heater coil section that would have caused or contributed to the reported event.The reported event is considered non-verifiable as the investigation identified that the heater coil successfully activated and detached the implant, but the evaluation also identified damage to the proximal connector that, if present during the procedure, would have caused or contributed to detachment difficulties.A medical review of the provided procedure notes was also performed.Based on the review of the procedure notes, the web device was clinically inserted and placed in the anatomically optimal position within the aneurysm with an associated inability to detach which required multiple attempts to detach the device with the use of two separate wdc units which finally lead to device detachment.The relationship of the event to the device is possible and cannot be ruled out.No device malfunction was reported and/or no device malfunction was reported as associated with or contributing to the adverse event.

• 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: 18374384
• MDR Text Key: 331378819
• Report Number: 2032493-2023-01140
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00840273200246
• UDI-Public: (01)00840273200246(11)230927(17)280831(10)0000423649
• 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,Followup
• Report Date: 02/14/2024

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: W5-7-3-MVI-MDR
• Device Lot Number: 0000423649
• 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: 11/26/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/04/2024; 02/02/2024
• Supplement Dates FDA Received: 02/03/2024; 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• 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
• Treatment: VIA-17 MICROCATHETER
• Patient Sex: Female