MAUDE Adverse Event Report: MICROVENTION, INC WEB SL 17 SINGLE LAYER; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number W5-4.5-2-MVI-3

Device Problems Separation Failure (2547); Difficult or Delayed Separation (4044)

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

Event Date 01/07/2024

Event Type  malfunction  

Event Description

It was reported the physician was implanting a 4.5 x2 web, lot 0000286775, in a ruptured basilar tip.The wdc detacher was green on the back table during prep but after deployment the web would not detach.Detachment was attempted with multiple detachment controllers with no success, and it was removed.Physician then went up to a 5x2 web and the detacher was green on the back table.After deployment the web would not detach but physician was able to break off the pusher wire at the detachment point.The web looked good, and the patient is stable.Please note this submission captures the separation failure issue with the 4.5 x2 web, lot 0000286775.The difficult / delayed separation issue with the 5x2 web was submitted under fda mdr # 2032493-2024-00093.

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combinations did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Items returned for evaluation: -pusher -implant -4x wdc-2 items not returned for evaluation: -introducer -dispenser hoop -microcatheter the web implant was returned still attached to the pusher for analysis.Upon inspection of returned items, the web implant was found to be within visual and dimensional specifications (spec: diameter(mm)= 4.5 ± 0.5, height(mm)= 2.0 ± 0.3) , but the pusher was broken at the hypotube to connector junction.Continuity and resistance testing was unable to be performed due to the broken pusher.The heater coil section was dissected to investigate any obstruction that could possibly prevent the implant from detaching, and the heater coil was found to be stretched which is 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 heater coil did show signs of controller activation as indicated by the melted tether and pet.The returned controllers were evaluated and found to be functioning as normal (see controller evaluations below).Controller investigation - controller 1 voltage and duration measurement: the wdc-2 board voltage and firing duration was measured using an oscilloscope.When the wdc-2 was inserted into the test fixture, a green light appeared with normal audio output.Voltage: 11.4v (specification: 11.2 - 11.8v) duration: 743.2ms (specification: 660 - 820ms) the wdc-2 board voltage and duration was found to be within specification.Controller investigation ( controller 2 voltage and duration measurement): the wdc-2 board voltage and firing duration was measured using an oscilloscope.When the wdc-2 was inserted into the test fixture, a green light appeared with normal audio output.Voltage: 11.3v (specification: 11.2 - 11.8v) duration: 763.5ms (specification: 660 - 820ms) the wdc-2 board voltage and duration was found to be within specification.Controller investigation (controller 3 voltage and duration measurement): the wdc-2 board voltage and firing duration was measured using an oscilloscope.When the wdc-2 was inserted into the test fixture, a green light appeared with normal audio output.Voltage: 11.2v (specification: 11.2 - 11.8v) duration: 750.4ms (specification: 660 - 820ms) the wdc-2 board voltage and duration was found to be within specification.Controller investigation ( controller 4 voltage and duration measurement): the wdc-2 board voltage and firing duration was measured using an oscilloscope.When the wdc-2 was inserted into the test fixture, a green light appeared with normal audio output.Voltage: 11.4v (specification: 11.2 - 11.8v) duration: 753.9ms (specification: 660 - 820ms) the wdc-2 board voltage and duration was found to be within specification.The investigation of the returned web system found the pusher broken at the hypotube to connector junction, and the heater coil windings stretched.Continuity and resistance testing could not be performed on the device due to the broken pusher.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 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 broken pusher, but the break is consistent with the device experiencing forces over specification.The returned detachment controllers were found to function as intended and would not have caused or contributed to the reported event.

• Brand Name: WEB SL 17 SINGLE LAYER
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18809135
• MDR Text Key: 337098875
• Report Number: 2032493-2024-00176
• Device Sequence Number: 1
• Product Code: OPR
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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-MVI-3
• Device Lot Number: 0000286775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: WDC-2 LOT 0000316672; WDC-2 LOT 0000374280; WDC-2 LOT 201112115; WDC-2 LOT 212021814V