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

Model Number VAMF4242C150TU

Device Problem Difficult To Position (1467)

Patient Problem Perforation of Vessels (2135)

Event Date 05/08/2018

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 for implantation in a patient for the endovascular treatment of an unknown size thoracic aortic aneurysm.It was reported that during the index procedure, the physician attempted to insert the device but once at the aortic arch it would not pass over the arch, even after several attempts.During this process the iliac vein tore and the device was removed to get control of the iliac vein.He then attempted to pass the device again but it would still not pass.Another longer stent graft was then used which was successfully deployed and implanted to complete the procedure.As per the physician, the cause of the event was anatomy related.No additional clinical sequelae were reported and the patient is fine.

• 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: 7552087
• MDR Text Key: 109481356
• Report Number: 2953200-2018-00784
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169346932
• UDI-Public: 00643169346932
• 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: 05/30/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2018
• Device Model Number: VAMF4242C150TU
• Device Catalogue Number: VAMF4242C150TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/30/2018
• Date Device Manufactured: 05/16/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR