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

Model Number	VAMF4242C200TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Dysphasia (2195)
Date of Event	12/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant captivia was implanted during the endovascular treatment of a 70mm thoracic aortic aneurysm.It was reported during index procedure prior to placing the valiant graft, the physician performed a left carotid to left subclavian bypass.While attempting to plug the left subclavian artery distal to the vertebral artery the non-mdt occluder kept pulling back.The physician unsuccessfully made serval attempts until a clot was identified on the occluder and it was noted that the long 7fr.Destination sheath had no blood flow and also contained a clot.The physician then decided not to occlude due to having to cross over the vertebral artery numerous times and also due to the presence of the clot.The physician then implanted the valiant captivia stent graft at the level of the carotid artery.The day after the index procedure the patient had symptoms of aphasia and a ct confirmed a stroke.No endoleaks were identified.As per the physician the cause of the stroke was due to the placement of the non-mdt device.No additional clinical sequelae was provided and the patient will be monitored.
Additional Manufacturer Narrative
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 ; 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: 13017023
• Report Number: 9612164-2021-04884
• Device Sequence Number: 12006026
• Product Code: MIH
• UDI-Device Identifier: 00643169346536
• UDI-Public: 00643169346536
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/16/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2023
• Device Model Number: VAMF4242C200TU
• Device Catalogue Number: VAMF4242C200TU
• 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: 12/10/2021
• Initial Report FDA Received Date: 12/16/2021
• Date Device Manufactured: 04/08/2021
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Male