MAUDE Adverse Event Report: MICROVENTION INC. WEB ANEURYSM EMBOLIZATION SYSTEM; INTRASACCULAR FLOW DISRUPTION

Model Number	W4-7-4
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation, but has not yet been returned.The product issue reported 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 the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Potential complications as referenced on the ifu, include but are not limited to the following: hematoma at the site of entry, aneurysm rupture, emboli, vessel perforation, parent artery occlusion, hemorrhage, ischemia, vasospasm, clot formation, device migration or misplacement, premature or difficult device detachment, non-detachment, incomplete aneurysm filling, revascularization, post-embolization syndrome, and neurological deficits including stroke and death.
Event or Problem Description
It was reported that the web device was positioned but would not detach with multiple detachment attempts with the detachment controller.The device was withdrawn from the patient and the case was successfully completed with another device.The patient was reported to be normal and there was no reported patient harm or injury.
Additional Manufacturer Narrative
Procedure/medical information review: four radiographic files were provided for review, two jpeg images and two short videos.They are not labeled as to time or date, nor which ica is being imaged.The review of the files is as follows: customer video_3: 6-second video of ica dsa, oblique, subtracted, with contrast.A web is seen in a small to medium acom aneurysm.It is open, not detached, and the pusher marker is just beyond the distal marker of the via catheter.Customer video_4: 5-second video of ica dsa, oblique, subtracted, with contrast.A web is seen in a small to medium acom aneurysm.It is open, not detached, and the pusher marker is just beyond the distal marker of the via catheter.Customer image_1: single shot oblique skull radiograph, unsubtracted, no contrast.A web is seen in the previously described small to medium acom aneurysm.It is open, not detached, and the pusher marker is just beyond the distal marker of the via catheter.Customer image_2: single shot oblique skull radiograph, unsubtracted, no contrast.A web is seen in the previously described small to medium acom aneurysm.It is open, not detached, and the pusher marker is just beyond the distal marker of the via catheter.These images do not explain why the web did not detach.The investigation of the returned coil system found the hypotube kinked at the proximal section and broken at the hypotube to connector junction.The proximal portion of the delivery system was not returned for evaluation.Due to the condition of the returned delivery system, this investigation could not test or assess the continuity or resistance of the device to determine if a condition existed that would have caused or contributed to the reported detachment issue and therefore, this complaint is considered non-verifiable.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.
Event or Problem Description
No additional information was received, please see h6 & h11.

• Brand Name: WEB ANEURYSM EMBOLIZATION SYSTEM
• Common Device Name: INTRASACCULAR FLOW DISRUPTION
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19727621
• Report Number: 2032493-2024-00535
• Device Sequence Number: 15486486
• Product Code: OPR
• UDI-Device Identifier: 00842429107096
• UDI-Public: (01)00842429107096(11)211116(17)251031(10)0000119420
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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 Expiration Date: 10/31/2025
• Device Model Number: W4-7-4
• Device Lot Number: 0000119420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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
• Patient Sex: Unknown