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

Model Number	VAMC3838C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Insufficient Information (4580)
Date of Event	04/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captiviastent graft was implanted in a patient for the endovascular treatment of a 64 mm thoracic aortic aneurysm.It was reported that the patient's two year follow up ct showed a type ia endoleak.The cause of the event is unknown.No intervention was required.No clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
The event date the type ia endoleak has been updated to (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received: it was reported that the reported valiant captiva stent graft was implanted distally to the previously implanted main stent graft system and was not involved in the type ia endoleak event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
It was reported that the patient has had intervention and a secondary procedure has taken place.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received; it was reported that a type ia endoleak was identified at the 5 year follow-up imaging.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The event outcome has been updated to unresolved not treating.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 TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8198699
• Report Number: 2953200-2018-01714
• Device Sequence Number: 16664476
• Product Code: MIH
• UDI-Device Identifier: 00643169346840
• UDI-Public: 00643169346840
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/17/2021

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: 03/04/2018
• Device Model Number: VAMC3838C150TU
• Device Catalogue Number: VAMC3838C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/27/2018; 05/02/2019; 12/01/2020; 07/12/2021; 08/26/2021
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/15/2019; 05/27/2019; 12/17/2020; 08/09/2021; 09/17/2021
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 59