MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number VAMF3636C200TE

Device Problem Inability to Irrigate (1337)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant thoracic stent graft system was implanted in the patent for the endovascular treatment of a thoracic aortic ulcer.During the index procedure, it was reported that while the device was being prepared for use, the valve would not completely discharge the irrigation fluid.The physician requested that a non-medtronic replacement device was to be used to complete the procedure.As per the physician, the cause of the event can not be determined.No clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Device evaluation summary: a gap of 1mm was observed between the end of the stent graft cover and the tapered tip; specification is 1-1.5mm.The stent graft and graft cover were slightly curved.A syringe was attached to the side port to irrigate the graft cover.Liquid was observed leaking from the side port tubing.Visual inspection confirmed the presence of a small cut on the tubing in line with the barbed adaptor.It was not possible to irrigate the graft cover due to the leak.Additional information: the physician noted their concern that if the fluid in the valve was not fully discharged this may cause a gas embolism for the patient.It was noted that there was a large amount of gas in the stent, and it was still not discharged after several attempts.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7410552
• MDR Text Key: 104891875
• Report Number: 2953200-2018-00524
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2018
• Device Model Number: VAMF3636C200TE
• Device Catalogue Number: VAMF3636C200TE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2016
• 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 Age: 72 YR