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

Model Number VAMC3030C200TJ

Device Problem Inability to Irrigate (1337)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2018

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 a patient for the endovascular treatment of a 3 cm aortic dissection.It was reported that during preparation of the delivery system, 20 cc of heparinized saline could be injected.However, additional heparinized saline solution could not be delivered and it leaked.The attempt of releasing the air from the delivery system was given up, and the product was inserted and implanted without further attempt.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Device evaluation summary: no leak was detected when flushing the device with water.The handle was disassembled, and the device flushed; no leaks were detected in the assembly.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: 7282406
• MDR Text Key: 100663536
• Report Number: 2953200-2018-00262
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/20/2018

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: 11/06/2019
• Device Model Number: VAMC3030C200TJ
• Device Catalogue Number: VAMC3030C200TJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/20/2018
• Supplement Dates Manufacturer Received: 06/19/2018
• Supplement Dates FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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: 75 YR