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

Model Number	VAMC3838C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/25/2019
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 captivia stent graft was implanted in a patient for the endovascular treatment of a 64mm thoracic aortic aneurysm.It was reported that 5 days later, follow up identified enlarging of the distal thoracic aorta.Three weeks later, an additional endurant stent graft was implanted distally.Ballooning was completed proximally and distally with no evidence of endoleak at the end of the procedure.It was reported the patient received prbcs for treatment of post surgical anemia.Per the investigator the cause of the event is undetermined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information received; it was confirmed that there was no endurant used in this patient, this information was provided in error.A valiant device was used instead.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: patient age and patient weight updated.Correction: brand name updated.Facility details updated.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: 8730032
• Report Number: 9612164-2019-02509
• Device Sequence Number: 2003755
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2019

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?: No
• 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: 05/29/2019
• Supplement Date Received by Manufacturer: 07/09/2019; 11/07/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/06/2019; 12/03/2019
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 59