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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEQUENT MEDICAL, INC VIA-21 MICROCATHETER-US VIA-21-154-01FOR US

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SEQUENT MEDICAL, INC VIA-21 MICROCATHETER-US VIA-21-154-01FOR US Back to Search Results
Model Number FGA21154-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Extravasation (1842); Hemorrhage, Cerebral (1889); Thrombus (2101); Rupture (2208)
Event Date 10/01/2019
Event Type  Death  
Manufacturer Narrative

A search for non-conformance 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. The root cause of the event cannot be determined. However, the reported clinical information indicates there was no malfunction or issue with the microvention device. The instructions for use (ifu) identifies aneurysm rupture, vessel perforation, hemorrhage, vascular thrombosis, and death as potential complications associated with use of the device.

 
Event Description

It was reported that treatment was performed on a patient with ruptured aneurysms and a dual hemorrhagic stroke involving the distal anterior cerebral artery (aca) and the posterior communicating artery (pcom) on the same side. After successful implantation of two web devices and stasis of both aneurysms, the final angiography run demonstrated clot forming on the intermediate catheter (non-mv device) and the via microcatheter in the a2 artery. The via was removed, and aspiration and mechanical thrombectomy were performed. Extravasation was then noticed in the internal carotid artery and pcom origin. The web in the pcom aneurysm appeared to be intact with no visible deformations. A balloon was inflated at the site of extravasation, which reduced the bleeding. The patient was admitted to the icu. It was reported that the patient died approximately one week post-procedure; however, the cause and exact date of the patient's death are unknown. The physician did not consider there to have been a malfunction or issue with a microvention device.

 
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Brand NameVIA-21 MICROCATHETER-US VIA-21-154-01FOR US
Type of DeviceMICROCATHETER
Manufacturer (Section D)
SEQUENT MEDICAL, INC
11 a columbia
aliso viejo CA 92656
Manufacturer Contact
eva manus
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key9264704
MDR Text Key164573928
Report Number2032493-2019-00254
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150894
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device EXPIRATION Date06/30/2020
Device MODEL NumberFGA21154-01
Device Catalogue NumberFGA21154-01
Device LOT Number19051304
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/13/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/31/2019 Patient Sequence Number: 1
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