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

Model Number	VAMF3838C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Paralysis (1997); Obstruction/Occlusion (2422); Spinal Cord Injury (2432)
Date of Event	03/27/2021
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 the patient for the endovascular treatment of an 72mm thoracic dissection.24 hours post procedure the patient complained of chest pain and lost motor function of both legs.Ct revealed partial occluded brachial artery with approx.90% coverage of the lsa ostia.It was determined that the lsa coverage may be a contributing factor to the acute spinal cord injury.A spinal drain was placed into the patient and the main arterial pressure was driven up into the 90s.An additional stent was also placed.Per the physician, the cause of the event was user error.No additional clinical sequalae were reported and the patient is fine.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11693122
• Report Number: 9612164-2021-01547
• Device Sequence Number: 11640591
• Product Code: MIH
• UDI-Device Identifier: 00643169346956
• UDI-Public: 00643169346956
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2021

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: 02/16/2023
• Device Model Number: VAMF3838C150TU
• Device Catalogue Number: VAMF3838C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2021
• Initial Report FDA Received Date: 04/20/2021
• 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: Other; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 81