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

Model Number	VAMF2828C100TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant captivia stent graft was implanted in the patient for the endovascular treatment of 61mm diameter thoracic aortic aneurysm.The patient was originally treated for a saccular aneurysm that was close to the lsa so bypasses were needed to be performed.The physician then opted to implant the device landing distal to lcca and then used a laser to burn hole via lsa and then stenting withanother manufacturer¿s stent.It was reported that a follow-up ct showed an endoleak from the atrium stent which was expanding the saccular aneurysm.The physician elected to perform a left carotid to left subclavian bypass and embolized the ostium of the left subclavian artery.The physician then implanted a valiant stent graft (28x28) proximally landing distal to the left carotid artery.Balloon inflations were then completed within the stent graft and a thoracic aortogram was completed to check for endoleaks.Two subtraction angiograms were performed and it was revealed that there was still a contrast blush that the physician thought was possibly a type ii endoleak.The procedure was completed and the patient was given protamine, the physician elected to perform normal follow up in a month to check the possible type ii endoleak status.Per the physician the cause of the event is due to gutter leak from the atrium stent.No additional clinical sequelae were reported and the patient will be monitored by their physician.

• Brand Name: VALIANT CAPTIVIA
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6840948
• Report Number: 2953200-2017-01387
• Device Sequence Number: 1444478
• Product Code: MIH
• UDI-Device Identifier: 00643169347090
• UDI-Public: 00643169347090
• 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
• Report Date (Section B): 08/10/2017

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: 01/25/2018
• Device Model Number: VAMF2828C100TU
• Device Catalogue Number: VAMF2828C100TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 09/04/2017
• 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: 71 YR