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

Model Number VAMF4040C150TU

Device Problem Difficult To Position (1467)

Patient Problem Perforation of Vessels (2135)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A valiant stent graft system was planned to be implanted in a patient for the endovascular treatment of a 50-60mm diameter thoracic aortic aneurysm.It was reported during the index procedure that the device failed to track through the calcified aorta and the right iliac sustained a tear.The physician elected not to implant the valiant device and an open repair of the external iliac was completed.Per the physician, the cause of the event was due to calcified anatomy.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: VALIANT CAPTIVIA - FF
• 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: 7645279
• MDR Text Key: 112566071
• Report Number: 2953200-2018-00904
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169346949
• UDI-Public: 00643169346949
• 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: 06/28/2018

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: 11/20/2019
• Device Model Number: VAMF4040C150TU
• Device Catalogue Number: VAMF4040C150TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/28/2018
• Date Device Manufactured: 11/20/2017
• 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: 93 YR