MAUDE Adverse Event Report: MICROVENTION, INC. WEB SLS; INTRASACCULAR DEVICES

Model Number W5-6-S-MVI

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 02/29/2024

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 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.  .

Event Description

It was reported that the web was inserted in the patient and didn¿t detach after releasing the detacher with a green light.The physician tried to reach out with a microcatheter to detachment zone of the web without success.A red light was displayed on the detachment device.The physician decided to resheath the web and went in smoothly into the microcatheter.However, the web still became loose in the microcatheter.A new web was selected, with success.No patient harm or injury was reported.

Manufacturer Narrative

The investigation of the returned web system found the implant separated from the delivery system within the distal end of the microcatheter upon receipt as described in the reported event.The returned via 17 microcatheter was found kinked at 4cm from the distal tip, which would have caused or contributed to the web implant separating from the pusher while retrieving the device during the procedure.Further inspection of the web system found the proximal connector kinked, and the heater coil windings stretched.The device failed continuity and resistance testing due to the damaged proximal connector and heater coil windings.However, the heater coil pet and tether were found melted, indicating that the device was activated using a detachment controller during the procedure; therefore, the damage to the proximal connector and heater coil windings likely occurred post-activation.The stretched heater coil windings are an indication that the tether could have been caught in between the coil windings and caused the heater coil to stretch when the delivery system was pulled/retracted during the procedure.The physical evaluation of the device could not identify the conditions or circumstances that led to the delivery system 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.

Event Description

It was reported that : "web w5-6-s was selected and physicians did a pre-test with the wdc2-detacher.Green light.Web inserted in patient, web didn¿t detached after releasing the detacher with a green light.Physician tried to reach out with via catheter to detachment zone of the web without success.Suddenly, there was a red light on wdc-2.They decided to resheath the web.Web went smoothly into the via-catheter.However, web still became loose in the via catheter.They preserved the web in the via catheter for examination.New w5-5-s was selected, with success.".

• Brand Name: WEB SLS
• Type of Device: INTRASACCULAR DEVICES
• 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: 18956219
• MDR Text Key: 338734967
• Report Number: 2032493-2024-00235
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102152
• UDI-Public: (01)00842429102152(11)220727(17)270630(10)0000235178
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-6-S-MVI
• Device Lot Number: 0000235178
• Was Device Available for Evaluation?: No
• 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: 07/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1