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

Model Number FGA15080-040

Device Problems Unintended Movement (3026); Difficult or Delayed Separation (4044)

Patient Problems Hemorrhage/Bleeding (1888); Rupture (2208)

Event Date 07/20/2022

Event Type  Injury  

Event Description

It was reported that the web device did not fully detach on the first detachment.The via catheter was advanced slowly, and web detached.The case was reported to be difficult because of the anatomy and angle of the was aneurysm in with the via 27 and caused the web device to rotate.As a result, the aneurysm had a small rupture/bleed after, which was treated with an inflated a competitor balloon device for a few minutes, and the bleeding was then stopped.The patient was monitored overnight and did not re-rupture.The patient woke up okay and intact, and reported to be speaking and responding conversationally.The patient was held at the hospital for a few extra days for observation before discharge.

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 remains implanted in the patient and not available for return to the manufacturer for analysis; therefore, a product analysis could not be conducted, and the reported issue cannot be confirmed.

• 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: 15188175
• MDR Text Key: 297493608
• Report Number: 2032493-2022-00351
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00856956005817
• UDI-Public: (01)00856956005817(11)190729(17)240822(10)19072920
• 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
• Report Date: 07/20/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: FGA15080-040
• Device Catalogue Number: FGA15080-040
• Device Lot Number: 19072920
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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
• Patient Sex: Female