MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - CW; 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 05/10/2017

Event Type  malfunction  

Event Description

A valiant captivia stent graft system was selected for use in a patient for the endovascular treatment of a 50mm length thoracic aortic dissection.It was reported that while flushing the device, the saline solution did not reach the graft cover tip.When the syringe was pushed hard, solution leaked out of the handle.The physician suspected there might be a perforation somewhere.The physician was concerned that blood could leak through the perforation when the device is inserted into the patient¿s body.The device was therefore replaced with a backup device.The physician stated that the flushing was unsuccessful possibly because the flushing lumen was connected to somewhere.No clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

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

• Brand Name: VALIANT CAPTIVIA - CW
• 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: paola garnica ; 3576 unocal place; santa rosa, CA 95403 ; 7075661361
• MDR Report Key: 6608945
• MDR Text Key: 76619631
• Report Number: 2953200-2017-00911
• 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: 05/10/2017

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: 09/21/2018
• Device Model Number: VAMC3030C200TJ
• Device Catalogue Number: VAMC3030C200TJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 05/10/2017
• Supplement Dates FDA Received: 10/04/2017
• Date Device Manufactured: 09/21/2016
• 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: 44 YR