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

Model Number	VAMF4444C200TU
Health Effect - Clinical Codes	Death (1802); Perforation (2001); Loss Of Pulse (2562)
Date of Event	06/20/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant thoracic stent graft system was implanted in the patient for the endovascular treatment on a 63mm diameter thoracic aortic aneurysm.During the index procedure it was reported that as the device was being advanced the patients arterial pressure dropped and there was a loss of heart rhythm.The procedure was converted to an open repair and it was noted that there was a tear present in the aorta distal to the left subclavian artery.The stent graft was passed across the tear and deployed.A distal extension was also then deployed.It was reported that the patient expired.As per the physician the cause of the event was anatomy related due to the patient having a type 3 aortic arch.The physician additionally noted that no overt aggressive pressure was exerted.It was also noted that on opening the chest the aorta felt very thin.No additional clinical sequalae were reported.
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 TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7676819
• Report Number: 2953200-2018-00999
• Device Sequence Number: 16486226
• Product Code: MIH
• UDI-Device Identifier: 00643169346529
• UDI-Public: 00643169346529
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 10/03/2018

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: 04/16/2020
• Device Model Number: VAMF4444C200TU
• Device Catalogue Number: VAMF4444C200TU
• Device Lot Number: V07818843
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: Death; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 73