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

Model Number W4-6-3-MVI-3

Device Problem Separation Failure (2547)

Patient Problems Brain Injury (2219); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/26/2022

Event Type  Death  

Manufacturer Narrative

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.The device remains implanted in the patient and procedural images were not provided; therefore, the alleged product issue cannot be confirmed.

Event Description

As reported during a procedure to treat a ruptured aneurysm with a web device, multiple unsuccessful attempts were made to detach the web device form the pusher wire.The physician decided not to remove the web once it was deployed as the physician thought it would do more harm to the patient to remove it.The physician ended up leaving the web in place and cutting the delivery wire at the groin.The web and delivery wire were left in the patient.The placement of the web was not ideal, and a stent was placed so it would not move.There are no plans to address the pusher, other than leaving it in patient.The patient was reported to be doing poorly and was sent home on hospice.

Manufacturer Narrative

A user medwatch was received (mw5111148) on aug 1st, 2022, containing additional information about this previously reported complaint.The patient was 52 years old.They were being treated for a ruptured aneurysm of the anterior communicating artery.The stent was placed in the left aca.The patient was reported to have suffered an irreparable brain injury and later passed away.The instructions for use (ifu) identifies death as a potential complication associated with use of the device.

Manufacturer Narrative

Additional information was received for medwatch report (mw5111148) on aug 30, 2022, containing cds images.No product was returned for evaluation, but several dicom image series were provided.The images show the web well positioned in the aneurysm, then sitting lower over time.A microcatheter is observed in the left a1 and a stent bridges the left a1 and the proximal left a2.The web is observed in the aneurysm with the pusher seen proximally in lica.The non-detached pusher wire extends from the web down the left a1, intracranial left ica to mid-cervical spine level, where the scan ends.There is infarction of the entire left aca territory (as evidenced by hypodensity), with mass effect and midline shift.The remainder of the pusher wire extends from the thoracic aorta, through the abdominal aorta, the common and external iliac arteries, and ends in the proximal femoral artery.These images confirm the complaint and show the web still attached to the pusher; however, the reason for the non-detachment of the web is not seen in these images.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: WEB SLS
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• 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: 14983464
• MDR Text Key: 295674164
• Report Number: 2032493-2022-00267
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429107034
• UDI-Public: (01)00842429107034(11)200714(17)250630(10)200714127
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W4-6-3-MVI-3
• Device Catalogue Number: W4-6-3
• Device Lot Number: 200714127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Death
• Patient Age: 52 YR
• Patient Sex: Female