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

Model Number	VAMC4444C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intimal Dissection (1333); Death (1802); Pain (1994)
Date of Event	05/10/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: v amf4040c200tu, serial/lot #: (b)(4), ubd: 13-feb-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of 75mm thoracic aortic aneurysm.It was reported that the patient presented emergently approximately four months later with severe chest pain and a ct showed a retrograde type a dissection.The patient underwent emergency aortic root replacement with reimplantation of the right coronary with an insitu saphenous vein graft.And replacement of the ascending aorta.The event is reported to be resolved.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Product analysis conclusion: the reported type a retrograde dissection was confirmed on the films received; however, the cause of the event could not be determined.Pre-implant ct¿s did not reveal any anatomical characteristics that may have contributed to the dissection and analysis of the returned post-implant films did not reveal any anatomical characteristics that could explain the reported dissection.The valiant stent graft that was implanted proximally provided an adequate seal of 3-4 stents before coverage of the taa and entry into the type b dissection.Analysis of the received films did not show any obvious stent graft integrity issues.It is unclear if the type a dissection was due to an unknown patient related issue or pre-existing condition, or possibly caused by an unknown interaction with the implanted stent grafts.Additional information received: it was reported that the patient expired the following day after presenting emergently with the type a dissection.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10060532
• Report Number: 9612164-2020-01888
• Device Sequence Number: 3514777
• Product Code: MIH
• UDI-Device Identifier: 00643169346819
• UDI-Public: 00643169346819
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: 06/10/2020
• Device Model Number: VAMC4444C150TU
• Device Catalogue Number: VAMC4444C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Initial Date Received by Manufacturer: 05/10/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 06/16/2020
• 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: 45 YR
• Patient Weight: 69