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

Model Number	VAMF3838C200TU
Medical Device Problem Codes	Difficult To Position (1467); Difficult to Remove (1528)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/23/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A talent stent graft system was implanted in the patient for an unknown endovascular treatment.It was reported that a valiant captivia stent graft system was implanted in the patient for the endovascular treatment of an 90mm thoracic aortic aneurysm.An aneurysm had reportedly developed above and below the previously implanted talent stent graft.During the procedure, access was by right subclavian cutdown.The device was not long enough to get to the innominate artery due to tortuous vessels.The physician deployed the device without the nose cone into the innominate artery.Upon trying to remove the device, the top cap became stuck on the free flow stents.While trying to remove the device the patient crashed and expired.The physician reported the cause of the event to be patient anatomy related due to tortuous vessels.

• Brand Name: VALIANT CAPTIVIA
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7442414
• Report Number: 2953200-2018-00571
• Device Sequence Number: 11124332
• Product Code: MIH
• UDI-Device Identifier: 00643169346550
• UDI-Public: 00643169346550
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2019
• Device Model Number: VAMF3838C200TU
• Device Catalogue Number: VAMF3838C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 81 YR