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

Model Number W5-5-3

Device Problem Difficult or Delayed Separation (4044)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/26/2023

Event Type  Death  

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 web remains implanted in the patient; however, the pusher and device imaging were reported to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged product issue could not be confirmed.If the device and/or subsequent reports are received at a later date, an investigation will be performed and a supplemental mdr will be submitted.

Event Description

It was reported that the physician was treating a ruptured anterior communicating artery (acom) aneurysm and included the use of a web device.The reporter indicated that the web was unable to detach with the first wdc-2 controller.The physician then reportedly used three more wdc-2 controllers multiple times each; however, the web did not detach.The physician then decided to stabilize the web device with a y-stenting.Administration of 500 asa and 500 heparin iv and y stenting performed from the right a2 into the right ai, and from left a2 into the right ai with no reported complications.After the placement of the stent, it was reported that he tried again to detach the web, and after additional manipulation, the web detached, and the aneurysm was closed.Further imaging showed a thrombus inside the stent in the proximal right a2, and the report was that the physician then used tirofiban adapted to the body weight, and no evidence of new bleeding reported after external ventricular drainage (evd).Over a period of approx.25 minutes, 2 angio controls were performed, and found the thrombus did not coarsen, but did not become significantly smaller, and there was no evidence of a perfusion delay or distal thromboembolism.Decision was made to terminate the intervention, with post operative plan for tirofiban iv weight-adapted for the next 24 hours or at least until the next morning, then planned switch to prasugrel; however, it was reported that the patient later expired later that night on (b)(6) 2023, from the subarachnoid hemorrhage and multiple hemorrhages.The report from the physician attributed the patient¿s death from the tirofiban medication with subsequent multiple hemorrhages encountered a few hours post procedure.

Event Description

Please see section h10 for investigation conclusion.

Manufacturer Narrative

Investigation conclusion: microvention received back part of the web detachment controller and delivery system; ten radiographic images; and physician¿s operative report that were provided for review.None of the radiographic images are labeled as to date or time.The internal medical review of the radiographic images is as follows: ¿two axial head ct scan images, without contrast: there is copious subarachnoid hemorrhage.A very large hematoma is seen in the region or the interhemispheric fissure, from the ruptured acom aneurysm.The temporal horns are dilated, indicating hydrocephalus.Three single-shot un-subtracted x-rays without contrast show a guiding catheter in the right petro cavernous junction.A via catheter is seen with its tip in the presumed location of the mid-right a1.A non-detached web is seen in the acom aneurysm.An ap oblique subtracted right ica dsa with contrast shows the non-detached web in the aneurysm, with some mild impaired flow across the acom into the left a2.The web protrudes slightly into the parent artery.The catheter is close to the base of the web.An ap oblique un-subtracted right ica dsa with contrast then shows placement of two stents for y-stenting.The proximal end of both stents are in the proximal 1/3 of the right a1.The web is not detached, and the catheter is close to the base of the web.Thrombus is seen in the stent in the proximal right a2.An ap oblique un-subtracted right ica single shot without contrast shows the y-stent construct.The catheter is still in the same position, so it is assumed that the web is not detached yet.Two images, an ap oblique un-subtracted right ica dsa with contrast and an ap oblique subtracted right ica dsa with contrast show that the via has been removed, the web is detached, there is persistent clot in the stent at the origin of the right a2, there is no flow restriction, and good crossflow through the acom into the left a1 and a2.These images do not explain why the web took so many attempts/maneuvers until it finally detached.¿ the web implant was not returned for evaluation as it was implanted in the patient as described in the reported event.The investigation report of the returned web detachment controller and delivery system reported that the implant separated from the delivery system, the proximal connector ¿kinked¿ at the brown lead wire joint, and the heater coil windings ¿stretched¿.The device failed continuity and resistance testing due to the damaged connector and heater coil windings, which is consistent with non-detachment.However, 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 connector and 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.An internal medical review of the provided operative report, dated november 26, 2023, was also performed.Based on microvention's post-market clinical product safety manager's medical opinion in a corresponding report, the report states ¿the relationship to the sah to the administration of 500mg asa iv, 5000ie heparin iv and tirofiban iv cannot be ruled out.The medical review finds that the relationship to the sah and the use of the web may be a potential contributing factor and as such, the use of the web to the sah cannot be definitively ruled out.¿ 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.Microvention is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by microvention, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Microvention has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, microvention, or its employees that the device, microvention, or its employees caused or contributed to the event described in the report.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: WEB SL
• 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: 18320891
• MDR Text Key: 330403257
• Report Number: 2032493-2023-01115
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102114
• UDI-Public: (01)00842429102114(11)230208(17)280131(10)0000320157
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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
• Device Operator: Health Professional
• Device Model Number: W5-5-3
• Device Lot Number: 0000320157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• 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): Death
• Patient Sex: Female