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

Model Number	VAMC4242C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: vamc4242c200tu, serial/lot #: (b)(4), ubd: 27-may-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 a thoracic aortic aneurysm.It was reported that approximately one week later, a type iii junctional endoleak was noted between the first and second stent grafts in zone 3.The patient was hospitalized as a result of this event.The event was assessed by the investigator as not related to the device, related to the procedure.The sponsor assessed the event as possibly related to the device and related to the procedure.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Updated post completion of investigation.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: 8120966
• Report Number: 9612164-2018-03437
• Device Sequence Number: 1656916
• Product Code: MIH
• UDI-Device Identifier: 00643169346734
• UDI-Public: 00643169346734
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/28/2019

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: 02/28/2020
• Device Model Number: VAMC4242C200TU
• Device Catalogue Number: VAMC4242C200TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 02/28/2019
• 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: Hospitalization
• Patient Age: 61 YR
• Patient Weight: 52