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

Model Number W5-7-3-MVI-3

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

Patient Problems Hemorrhage/Bleeding (1888); Ruptured Aneurysm (4436)

Event Date 05/17/2022

Event Type  Injury  

Event Description

It was reported during a treatment of a basilar apex aneurysm with a web device, placement was difficult and during multiple repositioning attempts, the aneurysm was ruptured.The aneurysm was measured, and a 8x3 web device was chosen.The device was deployed and encroached on the right pca.The 8x3 web device was removed and a 7x3 web device was selected.The web device was deployed and encroached on the right pca.The device was removed and an angled via 17 device was positioned within the aneurysm.The same web device was then attempted to be deployed for the second time, however the device was still encroaching on right pca.Both the web and via devices were removed and a different angle catheter (90 angle) was chosen to get a better position within the aneurysm.The same web was repositioned a third time, when the aneurysm ruptured.The web was left in place to assist tamponade.The physician inserted a balloon to assist in controlling the bleed.The bleed was controlled with coiling and detachment of the web.Additional information received indicated that the web was fully deployed outside the catheter during the aneurysm rupture.The patient's current status is unknown.

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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14595347
• MDR Text Key: 293301895
• Report Number: 2032493-2022-00227
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110928
• UDI-Public: (01)00842429110928(11)211115(17)241031(10)0000119424
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170023
• 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: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: W5-7-3-MVI-3
• Device Catalogue Number: W5-7-3
• Device Lot Number: 0000119424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VIA-17-154-45, 45 DEGREE, LOT UNK; VIA-17-154-90, 90 DEGREE LOT 0000079182
• Patient Outcome(s): Other
• Patient Sex: Female