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

Model Number	VAMF3636C200TU
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant devices are: vamf3636c200tu ; s/n: (b)(4); use by date: 2018-06-17; upn # (b)(4).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 for the endovascular treatment of thoracic aortic aneurysm of an unknown size.It was reported that, approximately 1.5 years post index procedure, the patient presented emergently to the er.A ct showed that the valiant stent graft had migrated 7cm further up into the thoracic aorta, leading to aneurysm growth and a slow type ib endoleak.Intervention was carried out on the same date, 2 x valiant stent graft systems were implanted without incident to cover the observed rupture and to cover down as far as the celiac arteries, where the initial stent graft system had originally been implanted.As per the physician, the cause of the event was due to angulation in the distal thoracic aorta.No additional clinical sequelae were reported, and the patient is fine.

• 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: 7298721
• Report Number: 2953200-2018-00283
• Device Sequence Number: 11075301
• Product Code: MIH
• UDI-Device Identifier: 00643169346567
• UDI-Public: 00643169346567
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/27/2018

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: 06/10/2018
• Device Model Number: VAMF3636C200TU
• Device Catalogue Number: VAMF3636C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 02/27/2018
• 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: Required Intervention
• Patient Age: 74 YR