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

Model Number W5-6-2-MVI-3

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

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

Event Date 05/25/2023

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 for analysis, but has not yet been received; therefore, the alleged product issue cannot be confirmed at this time.If the device or 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

As reported, the web device was used to treat a 4.9mm x 3.0mm pcomm aneurysm.The web would not detach and during maneuvering, the physician tried slight reverse traction on the pusher wire and used the detachment controller to detach the web.After detachment, the physician used a scepter xc balloon catheter to re-position the web device; however, the guidewire used with the scepter xc balloon pushed the web out of the aneurysm.The physician used a snaring device to retrieve the device out of the patient and used a new web sl device to successfully complete the case.Outcome was good and patient was discharged.

Manufacturer Narrative

Summary of device evaluation: the investigation of the returned web system found the implant detached from the delivery system, the proximal connector kinked, and the heater coil windings stretched.The device failed continuity and resistance testing due to the damaged heater coil winding and connector.However, the implant tether was found melted, indicating that the device was activated using a detachment controller during the procedure; therefore, the damage to the heater coil windings likely occurred post-activation.The stretched heater coil condition is consistent with the web implant getting caught in between the windings due to the implant tether increasing in diameter as it gets heated from the thermal activation of the detachment controller and exceeding the inner diameter of the heater coil, resulting in the web sticking to the pusher post-activation.The physical evaluation of the device could not identify the conditions or circumstances that led to the connector damage, but the damage is consistent with the device experiencing forces over specification.The returned detachment controller was found to function as intended and would not have caused or contributed to the reported 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: 17099511
• MDR Text Key: 316897580
• Report Number: 2032493-2023-00786
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429117996
• UDI-Public: (01)00842429117996(11)230419(17)260331(10)0000348500
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-6-2-MVI-3
• Device Catalogue Number: W5-6-2
• Device Lot Number: 0000358500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female