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

Model Number VAMF3434C200TU

Device Problem Difficult To Position (1467)

Patient Problem Perforation of Vessels (2135)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A valiant captivia stent graft system was planned to be implanted in a patient for the endovascular treatment of an unknown size thoracic aortic aneurysm.It was reported that the physician was unable to pass the valiant captivia stent graft system (b)(4) into the main right femoral artery and was unable to get the device to the desired location.The access vessel size was reported to be 8-9mm and non-calcified.Multiple attempts were made but the graft could not pass.Another manufacturers 24 french sheath was then passed through the access vessel and the vessel dissected.A non-mdt stent graft was implanted to resolve the dissection and the case was aborted.The physician attributed the cause of the event to the patients anatomy and reported that access was extremely difficult.The difficulty with access was not expected due to the size of the access vessels.No additional clinical sequelae were reported and the patient is being monitored.

• 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: 7510015
• MDR Text Key: 108086444
• Report Number: 2953200-2018-00696
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169347366
• UDI-Public: 00643169347366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• 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
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2019
• Device Model Number: VAMF3434C200TU
• Device Catalogue Number: VAMF3434C200TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/14/2018
• Date Device Manufactured: 05/24/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 88 YR