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

Model Number W5-5-2-MVI

Device Problems Device Dislodged or Dislocated (2923); Difficult or Delayed Separation (4044)

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

Event Date 03/24/2023

Event Type  Injury  

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 reported available for return but has not yet been received.Therefore, at this time, the product analysis could not be performed and the alleged product issue cannot be verified.If additional new information is received, a supplemental report will be submitted.

Event Description

It was reported that the web sl was used to treat a patient with two aneurysms, a posterior communicating artery (pcom) aneurysm and anterior communicating artery (acom) aneurysm.A web sl was deployed in the pcom aneurysm, but it could not be detached using multiple detachers and the device was removed from the patient without issues (ref: mfr report#: 2032493-2023-00654).To treat the acom aneurysm, a web sl device was placed but removed and exchanged for a larger size device.Reportedly, the replacement web sl device dislodged after detachment and encroached on the left aca with potential vessel occlusion.The web device was successfully retrieved and removed from the patient using a snare device (ref: mfr report#: 2032493-2023-00655).The patient two aneurysms were then treated with surgical clipping.According to the physician, there was no direct injury to the patient due to the use of the web device.Reportedly, the physician did not make a functional test of the devices prior to use.

Manufacturer Narrative

Correction: h6 (device problem code).Additional information: d10, h6, h10 (summary device evaluation).Summary device evaluation: the investigation of the returned web system found the implant detached from the delivery system and the implant tether melted, indicating the device did experience thermal activation.However, the delivery system was not returned for evaluation; therefore, this investigation could not test the electrical continuity of the circuit or assess the heater coil to verify if a condition existed that would have caused or contributed to the reported event.The investigation of the returned device did not find any other damage or anomaly that would have caused or contributed to the reported complaint.

• 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: 16702676
• MDR Text Key: 312898218
• Report Number: 2032493-2023-00654
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102107
• UDI-Public: (01)00842429102107(11)220519(17)270430(10)0000193157
• 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: 03/24/2023

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: W5-5-2-MVI
• Device Lot Number: 0000193157
• 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: 03/24/2023
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• 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 Outcome(s): Required Intervention