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

Model Number W5-5-2-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 web 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.

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.The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Event Description

No additional information was received, see h6 & h10.

Manufacturer Narrative

Items returned for evaluation: -delivery system (pusher) -4x wdc-2 items not returned for evaluation: -web implant -introducer -dispenser hoop -microcatheter the visual analysis of the returned items found the implant to be separated from delivery system and not returned.Tested the returned device with an in-house controller and gave red lights.The delivery system resistance was measured to be ol ¿ (spec= 66-78¿), which is out of specification.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.The heater coil did show signs of controller activation with an indication of a melted pet.The heater coil winding damage likely also contributed to the failed continuity and resistance testing.The returned controllers were evaluated and found to be functioning as normal.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: 11.4v (specification: 11.2 - 11.8v per cf11434) duration: 743.2ms (specification: 660 - 820ms per cf11434) 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 per cf11434) duration: 763.5ms (specification: 660 - 820ms per cf11434) 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 per cf11434) duration: 750.4ms (specification: 660 - 820ms per cf11434) 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 per cf11434) duration: 753.9ms (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, and the heater coil windings stretched.The implant was not returned for evaluation.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 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: 18611045
• MDR Text Key: 334662315
• Report Number: 2032493-2024-00093
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110843
• UDI-Public: (01)00842429110843(11)221003(17)250930(10)0000264599
• 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,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-5-2-MVI-3
• Device Lot Number: 0000264599
• 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: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• 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.