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

Model Number	VAMF4040C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Myocardial Infarction (1969); Occlusion (1984)
Date of Event	03/23/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Film evaluation summary: the cause of the reported retrograde type a dissection occurring 4 hours post-implant could not be determined from the pre-implant films provided.Films during implant were not available for review, and the stent graft in-vivo configuration could not be assessed.Pre-implant films confirmed that the patient had a type b dissection that originated just caudal to the lsa and extended distally to the level of the right external iliac artery.The thoracic was minimally tortuous with little observed calcification.It is possible that the patient¿s pre-existing dissection may have contributed to the retrograde type a dissection, which then led to the occlusion of right coronary artery, resulting in a massive right ventricular infarct and patient death.
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of a type b dissection from the left subclavian artery extending distally to right external iliac artery.It was reported that approximately 4 hours post implant the patient¿s blood pressure dropped.An echocardiogram revealed that the patient had a type a retrograde dissection with occlusion of right coronary artery resulting in a massive right ventricular infarct.The patient expired.Per the physician, the causes of the event cannot be determined.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6500440
• Report Number: 2953200-2017-00618
• Device Sequence Number: 1330579
• Product Code: MIH
• UDI-Device Identifier: 00643169346949
• UDI-Public: 00643169346949
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2018
• Device Model Number: VAMF4040C150TU
• Device Catalogue Number: VAMF4040C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: Death
• Patient Age: 76 YR