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

Model Number W2-8-5-MVI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/16/2022

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 device was implanted in the patient and not returned for evaluation.Procedural images were not provided.The root cause could not be determined.The instructions for use (ifu) identifies death as a potential complication associated with use of the device.

Event Description

It was reported that a web device was successfully implanted in a basilar tip aneurysm to treat a patient with an sah (hunt & hess grade iii).Control angiogram showed stasis of contrast inside of the aneurysm.Approximately 10 minutes later, a further angiogram showed bleeding out of a distal bleb of the aneurysm, the cause of which was not known.The patient's blood pressure was lowered and a stent was placed to reduce blood flow at the neck of the aneurysm.The patient passed away a short time later in the icu.The official cause of death was reported to be rebleeding (sah).

Manufacturer Narrative

Multiple attempts were made to obtain the operative report, autopsy report, procedural and post-procedural images, and any portion of the device that may have been retained.No operative report, autopsy report or device were provided; however, mvi did receive a cd containing dicom files (3.47 gb) which was supplied by the medical facility.It contained multiple folders of ct, cta, and dsa images, all date stamped with the reported event date of 8/16/2022.The images were reviewed by our physician; the cause for the delayed sah 9-10 minutes after the uncomplicated and successful positioning of the web in the aneurysm was not explainable from the images provided.Also, as previously reported, the attending physician could not offer an explanation for the bleeding.Without the return and physical evaluation of the device, this investigation cannot determine if a condition existed that would have caused or contributed to the reported event.However, there is no indication of any malfunction or non-conformity of the web device and the company notes that delayed aneurysmal bleeding is a well-recognized and warned about complication that can occur in the absence of product malfunction.

• 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: 15468310
• MDR Text Key: 300419195
• Report Number: 2032493-2022-00364
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102350
• UDI-Public: (01)00842429102350(11)210512(17)260430(10)210512117
• 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: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W2-8-5-MVI
• Device Lot Number: 210512117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• 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): Required Intervention; Death