MAUDE Adverse Event Report: MICROVENTION, INC. VIA MICROCATHETER; PERCUTANEOUS CATHETER

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

The lot number is unknown; therefore, a device history record review could not be performed.The devices remain implanted in the patients and not available for return to the manufacturer for analysis, and procedure images were not provided; therefore, the alleged product issue could not be confirmed.The instructions for use (ifu) identifies vessel dissection or perforation and hemorrhage as potential complications associated with use of the device.

Event Description

As reported through the journal article titled "intracranial aneurysm treatment with intrasaccular flow disruption: comparison of web-21 and web 17 systems", from june 2015 to november 2019, 87 patients with 92 aneurysms were treated with web-21 (38/92, 41.3%) and web-17 (54/92, 58.7%).Of the patients treated with the web-17, one patient developed the complications.Reportedly, post treatment with a web-17 for an unruptured mca aneurysm, an aneurysm sac perforation occurred during microcatheterization: the web was rapidly deployed in the aneurysm sac and the bleeding stopped a few minutes later.Flat panel ct performed at the end of the procedure and mri performed 24 hours post-procedure showed limited subarachnoid hemorrhage.Mrs score was 0 at hospital discharge.This is report 5 of 5.(ref.Mfr.Reports #: 2032493-2021-00455, 2032493-2021-00456, 2032493-2021-00458, and 2032493-2021-00459).

Manufacturer Narrative

Correction (suspect device): d1, d1, g4.

• Brand Name: VIA MICROCATHETER
• Type of Device: PERCUTANEOUS CATHETER
• 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: 12845191
• MDR Text Key: 284207589
• Report Number: 2032493-2021-00460
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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