MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number	W5-4.5-2-MVI-3
Medical Device Problem Codes	Separation Failure (2547); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and not returned to the manufacturer for analysis.Imaging was provided and its analysis is currently ongoing.
Event or Problem Description
It was reported that a web device was implanted in a right ica aneurysm but would not detach after the use of the detachment controller.The microcatheter was used to push the implant off of the delivery pusher, but the implant dislodged from the aneurysm.A stent was used to tack the protruding web against the arterial wall.The patient was reported to have woke up from anesthesia neurologically intact.The device was used in the same case as the device reported in 2032493-2023-00635.
Additional Manufacturer Narrative
Correction: g4: on initial report, the date received by manufacturer was stated as march 8, 2023.This is a typo.The correct date is march 6, 2023.H5 : labeled for single use question was corrected to answer as yes.H8 usage of device was answered as initial use of device.Six (6) angiographic images are supplied for this investigation.They are all blurry and of poor quality.They are not labeled as to side, date or time.Two issues are described in this report (one in each ica).The review of the provided images is as follows: image 1: poor quality ica oblique roadmap with very little contrast material.A medium sized aneurysm is seen, possibly in the pcom area.A microcatheter with only a few mm of unopened web is seen at the neck of the aneurysm.Image 2: single shot unsubtracted lateral radiograph centered on skull base, no contrast.A well opened pipeline flow diverter spans from the high supraclinoid ica/proximal m1 to just below the ophthalmic segment.A web is seen adjacent to the pipeline, off the posterior wall of the supraclinoid ica.Image 3: different, ap-ish projection, of the same as xavier bad web 2.I see a web with a lot of skull bone superimposed.The image is not interpretable.Image 4: same as xavier bad web 2, but with some small amount of contrast injected.Image 5: single shot unsubtracted ap radiograph centered on skull base; contrast seen in left ica circulation.A web is seen end-on in the proximal 1/3 of the supraclinoid ica, as both distal and proximal markers are almost superimposed.Image 6: single shot unsubtracted lateral radiograph centered on skull base, no contrast.A second well opened pipeline is seen spanning from the high supraclinoid ica to just below the ophthalmic segment.Posterior to it is a second web device.The previously described contralateral web and pipeline are also seen on this image.The complication described is not explained by these images.Without the return and physical evaluation of the device, the investigation cannot determine if a condition exists that would have caused on contributed to the reported event.

• Brand Name: WEB SL
• 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 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo 92656 ; 7142478000
• MDR Report Key: 16632976
• Report Number: 2032493-2023-00636
• Device Sequence Number: 7179815
• Product Code: OPR
• UDI-Device Identifier: 00842429110799
• UDI-Public: (01)00842429110799(11)220607(17)250531(10)0000202703
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: W5-4.5-2-MVI-3
• Device Catalogue Number: W5-4.5-2
• Device Lot Number: 0000202703
• Was Device Available for Evaluation?: No
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female