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

Model Number	VAMF3232C200TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Vascular Dissection (3160)
Date of Event	05/03/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captivia stent graft was implanted for an endovascular treatment.It was originally believed that the patient had a penetrating atherosclerotic ulcer.However, intravascular ultrasound revealed that it was a dissection.During the index procedure, after the valiant stent graft was implanted, the patient¿s right radial arterial line pressure decreased.The left arm cuff pressure was normal.An angiogram revealed that there was a retrograde type a dissection that extended to the aortic valve.The physician elected to convert the patient to open repair of the ascending arch.The patient was placed on cardiopulmonary bypass for 1.5 hours after the valiant stent graft had been deployed.During the open repair, it was noted that the entry tear was not near the bare stents of the valiant stent graft and the tear did not appear to have been caused by the device.The physician noted that the patient¿s tissue was very thin and it made it difficult to sew.The physician noted that the innominate artery was removed from the aorta by just using a finger and that it wasn't normal to be able to do that.After the graft was placed and sewn together, the patient was unable to be weaned off of the cardiopulmonary bypass pump and the patient expired.Per the physician, the cause of the retrograde type a dissection could have been due to the patient¿s anatomy of paper thin tissue or it could have occurred from the guide wire.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6592975
• Report Number: 2953200-2017-00870
• Device Sequence Number: 13769678
• Product Code: MIH
• UDI-Device Identifier: 00643169347137
• UDI-Public: 00643169347137
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2018
• Device Model Number: VAMF3232C200TU
• Device Catalogue Number: VAMF3232C200TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 05/03/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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
• Patient Age: 62 YR
• Patient Weight: 88