MAUDE Adverse Event Report: MICROVENTION, INC WEB SL 27 SINGLE LAYER; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number	W2-9-5-MVI-3
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: the device was returned to 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 or Problem Description
It was reported: web device was one-quarter deployed in the basilar apex aneurysm and the pusher wire detached from the device.The catheter was taken over the microcatheter and used to recapture most of the web device.The catheters and web were removed as a system from the patient.The patient¿s aneurysm was not treated during the procedure, patient is stable.
Event or Problem Description
Additional information received notes the wdc-2 was never used on the web device once it entered the patient.It was only used during the prep to check the web device.The physician¿s treatment plan was for the fredx 27 to open and cover the aneurysm.Because the fredx 27 did not open he decided to use the pipeline flow diverter.The hospital does not keep pipeline flow diverters in their inventory, so the patient needed to be rescheduled.
Additional Manufacturer Narrative
B5: additional information added.H10: returned items: - delivery system (pusher) - introducer - implant web - microcatheter - controller non-returned items: - dispenser hoop the visual analysis of the returned items found the implant to be separated from delivery system with no signs of controller activation and within dimensional specifications (spec: height(mm)= 5.0 ± 0.5, diameter(mm)= 9.0 ± 0.9).The pusher was returned kinked at the hypotube to connector junction.There were no visible damages found to the returned microcatheter that would have caused or contributed to the reported complaint.The heater coil section was dissected to confirm if there was a controller activation, and there were no signs of a melted tether or pet.However, the implant tether did show signs of a tensile break as indicated by the jagged edges on the proximal end of the tether tail.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 kinked hypotube to connector junction on the pusher.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: 11.6 v (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.The investigation of the returned web system found the pusher kinked and the implant to be separated from the pusher with no signs of activation using a detachment controller on the pusher heater coil.The investigation found the implant tether tail with a tensile break shape at the tip, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.No damage was found on the returned microcatheter that would have caused or contributed to the reported complaint.

• Brand Name: WEB SL 27 SINGLE LAYER
• Common Device Name: 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: 17040605
• Report Number: 2032493-2023-00758
• Device Sequence Number: 6908621
• Product Code: OPR
• UDI-Device Identifier: 00842429107201
• UDI-Public: (01)00842429107201(11)220113(17)261231(10)0000140491
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: W2-9-5-MVI-3
• Device Catalogue Number: W2-9-5
• Device Lot Number: 0000140491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SOFIA CATHETER; VIA 27 MICROCATHETER; WEB DETACHMENT CONTROLLER
• Patient Age: 67 YR
• Patient Sex: Female