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

Model Number	VAMC4238C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vascular Dissection (3160); Insufficient Information (4580)
Date of Event	04/29/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: v amf3838c100tu, serial/lot #: (b)(4), ubd: 30-apr-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Valiant captivia stent grafts were implanted during an endovascular procedure for the treatment of a 68mm thoracic aortic aneurysm.The physician implanted a vamf3838c150tu followed by vamc4238c150tu proximal to celiac.It was reported during the index procedure following the implant of the two valiant captivia stent grafts, ballooning was completed with reliant balloon at the overlap section and distal graft seal zone.On the final angiogram a type ia endoleak was observed.The physician at first thought it was as a result of the patient anatomy measuring 33-35mm.The physician ballooned the top of the graft which improved the endoleak.Another angiogram was performed and the graft was then extended proximally with a vamf3838c100tu.Ballooning of the overlap of graft was performed with reliant balloon.Final angiogram showed no endoleak and case was a technical success.Postprocedure, a few hours later, the physician noted the patient had woken up and was moving all extremities, but then the patient coded and cpr was commenced but the patient expired.As per the physician the cause of death could have been due to a type a dissection, but without imaging the physician was not certain and could not rule out if the death was device related or due to other factors.No additional clinical sequalae was provided and the patient has expired.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14285320
• Report Number: 9612164-2022-01660
• Device Sequence Number: 6209371
• Product Code: MIH
• UDI-Device Identifier: 00643169346703
• UDI-Public: 00643169346703
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

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: 11/18/2023
• Device Model Number: VAMC4238C150TU
• Device Catalogue Number: VAMC4238C150TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/05/2022
• Date Device Manufactured: 11/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male