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

Model Number	VAMF3030C100TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Fever (1858); Hematoma (1884); Pain (1994)
Date of Event	05/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant captivia stent graft was successfully implanted during endovascular treatment of a thoracic aortic aneurysm.During the procedure, a reliant stent graft balloon (rel46) was utilized to enhance contact between the stent graft and the vessel wall.The patient was discharged on the day of the procedure.It was reported on the same date, the patient returned to the emergency department later in the evening, reporting feeling very warm with a temperature of 102 °f.Additionally, the patient experienced ongoing back pain, which the patient thought to be attributed to the hospital beds.The patients white blood cell count was 15.3, which had been fluctuating.Blood cultures pending.The patient was commenced on an antibiotic treatment (vancomycin) the following day.Infection work up was negative.The patient was diagnosed with post implantation syndrome, related to the stent graft placement.The patients condition resolved 3 days later and the patient was then discharged from hospital.Additionally when the patient presented on the same day as the procedure, an incidental finding of a right groin retroperitoneal he maltoma associated with anemia was noted.No action was required for this and it resolved 3 days later.The site assessed the post implantation syndrome as having a causal relationship to the stent graft and possibly related to the index procedure.The sponsor assessed it as possibly related to the index procedure and related to the device.The site and sponsor assessed the hematoma as not related to the study device and possibly related to the study procedure.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VALIANT CAPTIVIA - FF
• 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: 19318367
• Report Number: 9612164-2024-02312
• Device Sequence Number: 20731038
• Product Code: MIH
• UDI-Device Identifier: 00643169347083
• UDI-Public: 00643169347083
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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: 05/08/2024
• Device Model Number: VAMF3030C100TU
• Device Catalogue Number: VAMF3030C100TU
• 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: 05/07/2024
• Initial Report FDA Received Date: 05/15/2024
• Date Device Manufactured: 05/09/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White