MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VESSEL EVERTER SYSTEM; DEVICE, ANASTOMOTIC, MICROVASCULAR

Catalog Number 519600001061

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

Patient Problem Thrombus (2101)

Event Date 01/16/2020

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient underwent a head and neck procedure with a vessel everter system device which was used to anastomose 2.0mm and 2.5mm arteries.It was reported no problems or issues were encountered during coupling.Approximately two hours intraoperatively, a clot located in an unspecified artery was noted.The coupler was cut out and the vessels were sutured and successful anastomosis was achieved with no negative impact to the patient outcome.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information:the device was not received for evaluation; therefore, a device analysis could not be completed.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VESSEL EVERTER SYSTEM
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9694118
• MDR Text Key: 178581343
• Report Number: 1416980-2020-00564
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190499
• 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,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 519600001061
• Device Lot Number: SP19F25-1381499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2020
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: VESSEL EVERTER ACCESSORY TOOL
• Patient Outcome(s): Other