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

Model Number W2-8-4-MVI-2

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Rupture (2208)

Event Date 06/20/2022

Event Type  Injury  

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 remains impanted in the patient; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies aneurysm perforation or rupture and hemorrhage as potential complications associated with use of the device.

Event Description

It was reported that the case was for an unruptured mca aneurysm measuring 7mm in width and 5.5mm in height treated by physician with a web device.The physician initially placed a 9x5 web sl, which was too big.The device was removed and an 8x4 web sl was placed instead.Reportedly, when the physician was unsheathing second web, the device fully came out, pushed forward and punctured the aneurysm.Angiogram showed extravasation of contrast confirming intra-procedural rupture.The physician detached the device and placed a balloon and inflated to block flow in the m1 and proceeded to place coils in the aneurysm.The physician placed an external ventricular drain on the table.The patient recovered.The physician suspects that the reason for the rupture was the lack of intermediate support.

Manufacturer Narrative

Image review: six angiographic images of the right ica in various projections are supplied.They are of poor quality and distorted.The initial dsa shows a wide neck mca bifurcation aneurysm.A subsequent image shows the web that is oversized and protrudes into the parent artery.Then, a partially opened, hourglass-shaped second web is seen in the aneurysm, with active extravasation of contrast into the subarachnoid space.The images do not appear the show the detached second web or of the balloon that was used to tamponade the hemorrhage.Perforations during web deployment are a recognized, rare complication.Detaching the web and tamponading with a balloon, the way the physician did, are the appropriate way to deal with that complication.The physical device was not available for evaluation, so the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.

• 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: 15029304
• MDR Text Key: 295984830
• Report Number: 2032493-2022-00255
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429104095
• UDI-Public: (01)00842429104095(11)190920(17)240831(10)19092032
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W2-8-4-MVI-2
• Device Lot Number: 19092032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2019
• 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
• Treatment: VIA 27 MICORCATHETER6F SOFIA PLUS CATHETER
• Patient Outcome(s): Other