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

Model Number W5-4-2-MVI-3

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

Patient Problem Insufficient Information (4580)

Event Date 07/29/2023

Event Type  Death  

Event Description

Based on a web pas clinical study report, the patient¿s family reported that the patient passed at home 31 days post-procedure.The cause of the death is due to unclear causes.The patient was reportedly in good health shortly before passing.It is unclear if cardiac arrest or secondary to a neurologic event occurred, and further, delayed rupture of a previously ruptured aneurysm that was treated by the web device cannot be excluded as a possible cause at this time, so a neurological death remains possible.Relationship to study device: possible.Relationship to index endovascular procedure: not related.Relationship to use of ancillary device: not related.Relationship to study disease: possible relationship to concomitant disease: not related.Ae outcome: fatal.

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues during manufacturing of the device relevant to the complaint that occurred.The device was implanted and therefore not available for return and investigation by the manufacturer.However, imaging and an operative report were provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 19084719
• MDR Text Key: 339875809
• Report Number: 2032493-2024-00285
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110812
• UDI-Public: (01)00842429110812(11)221013(17)250930(10)0000270365
• 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: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: W5-4-2-MVI-3
• Device Lot Number: 0000270365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 61 KG