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

Model Number W5-6-3-MVI

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

The device in question remains implanted.The ancillary devices used were stated to be returned to the manufacturer for evaluation but have not yet been received.The difficulty in separation 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.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: procedure was treatment of mca bifurcation.The web had been tested with the wdc-2 before insertion in the micro-catheter.After 4 attempts, the web was not detached.The physician did a pulling maneuver on the pusher to detach the web while holding the via 17.It is noted the patient is ok, the web remains implanted, no problem before the procedure, no medical complication.The procedure was successfully completed.

Manufacturer Narrative

Returned items: delivery system (pusher).Controller.Dispenser hoop.Microcatheter.Non-returned items: implant web.Introducer.The visual analysis of the returned items found the implant to be separated from the delivery system and was not returned for evaluation.The proximal connector was found kinked at multiple locations.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: 11.4 v (specification: 11.2 - 11.8v per cf11434).Duration: 744.0ms (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 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 received.

• 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: 17494812
• MDR Text Key: 321150950
• Report Number: 2032493-2023-00888
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102138
• UDI-Public: (01)00842429102138(11)230406(17)280331(10)0000343439
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-6-3-MVI
• Device Lot Number: 0000343439
• 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: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VIA 17, 54 45, LOT 0000295005; WDC 2, UNKNOWN LOT