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

Model Number	VAMF3434C200TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Vascular Dissection (3160)
Date of Event	11/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the retrograde type a dissection occurring 15 days after implant could not be determined from the five still images provided.The pre-implant anatomy information, films at implant, and additional films that showed the retrograde type a dissection were not provided.The complete stent graft in-vivo configuration could not be assessed.It is possible that the stent graft bare springs may have contributed to the event.The patient¿s pre-existing type b dissection also may have contributed.
Event or Problem Description
A valiant stent graft system was implanted in the patient for the endovascular treatment of a 260 mm in length thoracic aortic dissection.It was reported that fifteen days post index procedure the patient presented emergently with chest pain and a blood pressure of 200/104 mm hg.It was discovered that the patient had an acute type a dissection.The physician elected to perform an open repair of the ascending aortic arch and the event was resolved.Per the physician the cause of the event was due to the proximal bare spring of the valiant stent graft.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.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: 6138471
• Report Number: 2953200-2016-02048
• Device Sequence Number: 13741955
• Product Code: MIH
• UDI-Device Identifier: 00643169347366
• UDI-Public: 00643169347366
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2016

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: 01/04/2018
• Device Model Number: VAMF3434C200TU
• Device Catalogue Number: VAMF3434C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Initial Date Received by Manufacturer: 11/09/2016
• Supplement Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 09/27/2017
• 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: 77 YR
• Patient Weight: 72