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

Model Number W5-4.5-2-MVI-3

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 06/07/2023

Event Type  malfunction  

Manufacturer Narrative

The device in question remains implanted.The ancillary devices used in the procedure have been returned and received by the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.A search for non-conformances associated with this part/lot number combination and the part/lot combinations of the ancillary devices used, did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the devices.

Event Description

It was reported: the physicians treated a left mca.Aneurysm was average w- 3.18 and min h-3.They used 1 detacher and pressed button 4 times.It was a severe sticky tether and it moved the device slightly and web finally detached.The final lateral compression on ap was 2.89mm and lat was 4.4 widths.Patients' condition noted as good.The procedure was considered successfully completed.

Manufacturer Narrative

H10: returned items: - delivery system (pusher) - controller.Non-returned items: - dispenser hoop - implant web - introducer - microcatheter.The visual analysis of the returned items found the implant to be separated from delivery system and not returned for evaluation.The pusher hypotube was found kinked in multiple locations, and the proximal connector was found kinked at the brown lead wire junction.Tested the returned device with an in-house controller and the returned controller and gave red lights.The delivery system resistance was measured to be ol (spec= 66-78), which is out of specification due to the damaged connector.The heater coil section was then dissected to investigate any obstruction that could possibly prevent the implant from detaching, and the heater coil was found to be stretched and damaged, 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.Although, the device failed the continuity and resistance testing, the heater coil did show signs of controller activation with an indication of melted pet.The heater coil damage likely also contributed to the failed continuity and resistance testing.Controller investigation: 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: 11.3 v (specification: 11.2 - 11.8v per cf11434) duration: 729.8ms (specification: 660 - 820ms per cf11434) the wdc-2 board voltage and duration was found to be within specification.The investigation of the returned web system found the implant separated from the delivery system, the hypotube kinked, the proximal connector kinked, and the heater coil windings stretched and damaged.The implant was not returned for evaluation.The device failed continuity and resistance testing due to the damaged connector and heater coil windings.However, the heater coil pet 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 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 pusher 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

No additional information was received.Please see d10, h6 and h10.

• 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: 17495416
• MDR Text Key: 321236464
• Report Number: 2032493-2023-00892
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110799
• UDI-Public: (01)00842429110799(11)220517(17)250430(10)0000189728
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170023
• 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,Followup
• Report Date: 09/21/2023

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: W5-4.5-2-MVI-3
• Device Lot Number: 0000189728
• 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: 07/26/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BENCHMARK.; SOFIA 5FR 125.; VIA17- 45 DEGREE.
• Patient Age: 41 YR
• Patient Sex: Female