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

Model Number W5-5-2-MVI

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Ruptured Aneurysm (4436); Insufficient Information (4580)

Event Date 07/13/2022

Event Type  Death  

Event Description

It was reported that during treatment of an aneurysm the right mca with a web device, the web did not open satisfactorily.The microcatheter was pulled proximately to the aneurysm neck for a second attempt to place the web.The device was successfully detached, however, a few seconds later bleeding was noted in the area of the aneurysm.The bleeding was controlled.The exact location of the bleeding could not be determined.An external ventricle drainage (evd) was placed.It was reported that the patient later expired.

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 was implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The event as described could not be confirmed.

Manufacturer Narrative

A 2.92 gb dicom disc is supplied.It consists of multiple dsa angio runs of the right ica obtained on the day of the web procedure, (b)(6) 2022; the procedure starts at 12h05 and ends at 13h27.13h05: it appears the microcatheter may have perforated the aneurysm, as the extravasation pattern is different.At the 12h32 mark, a web has been placed in the aneurysm and is fully expanded.The microcatheter is just proximal to the web's base marker.There is active extravasation of contrast material from the aneurysm, indicating rupture/perforation.No images or fluoro images to show the maneuver(s) that led to perforation are supplied.Without this imaging, the investigation is unable to determine the exact cause of the perforation.Without the return and physical evaluation of the device, the investigation cannot determine if a condition existed that would have caused or contribute to the reported event.The operation report was also provided.The report states that, after the microcatheter is placed in the aneurysm, an angiogram is done to confirm its good position.The report then says that the web is placed in the aneurysm and fully deployed; an angiogram then shows extravasation.The report does not mention specifically at what stage of the placement/manipulation of the web did the perforation/extravasation occur, so it can only be concluded that the event occurred sometime between the final placement of the microcatheter and the full deployment of the web, and it cannot be determined what specific maneuver caused the perforation.The report also confirms that the iatrogenic hemorrhage caused increased intracranial pressure, which was treated by placement of a ventriculostomy.The perforation/hemorrhage are likely the primary cause death.

• 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 ; 9799890661
• MDR Report Key: 15196094
• MDR Text Key: 297568510
• Report Number: 2032493-2022-00288
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102107
• UDI-Public: (01)00842429102107(11)210104(17)251231(10)21010411B
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: W5-5-2-MVI
• Device Lot Number: 21010411B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• 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