MAUDE Adverse Event Report: MICROVENTION, INC. VIA-27 MICROCATHETER; PERCUTANEOUS CATHETER

Model Number VIA-27-154-01-MVI2

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

Patient Problem Extravasation (1842)

Event Date 05/21/2021

Event Type  Injury  

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.Procedural images were not provided for review; therefore, the event cannot be confirmed.The ifu identifies aneurysm perforation or rupture as a potential complication associated with use of the device.The device associated with this event was used during the same procedure referenced in mfr.Report # 2032493-2021-00243.

Event Description

It was reported that during treatment of an aneurysm, a via microcatheter and web device were advanced into position when an angiographic run revealed extravasation.It was not known if the web or the via caused the extravasation.Heparin was reversed and the next angiographic run revealed no further extravasation.The web was impeding flow in the parent vessel.A competitor's stent was placed in order to keep the web device in the aneurysm.Flow through the stent shut down and integrilin was administered, which restored flow.Post procedure, the patient was awake, following commands and moving their right and left legs.There was no reported sequelae.

• Brand Name: VIA-27 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: 12029483
• MDR Text Key: 257196215
• Report Number: 2032493-2021-00244
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00842429106426
• UDI-Public: (01)00842429106426(11)201209(17)231231(10)20120911G
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2021

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
• Device Model Number: VIA-27-154-01-MVI2
• Device Catalogue Number: VIA-27-154-01
• Device Lot Number: 20120911G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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