MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ENBF3216C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that the patient presented emergently with belly and back pain.A ct showed the patient had a 3 vessel snorkel procedure; and that the neck had continued to dilate causing a type ia endoleak to develop between the snorkels.It was noted that the aneurysm measured 8 cm in diameter two years ago but was 9.5 cm in diameter at the most recent scan.The patient was taken to the or and another manufacturer¿s stents were placed in the renal arteries and the superior mesenteric artery.A 36x36x100 valiant device was also place.An angiogram was performed and the endoleak remained.6 heli-fx endoanchors were then placed, but the endoleak was still present.The physician was able to place a wire between the snorkels and inject thrombin into the area of the endoleak.This reportedly resolved the event.The physician stated that the cause of the event was related to patient anatomy; specifically, disease pr ogression.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: ENDURANT BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6538909
• Report Number: 2953200-2017-00714
• Device Sequence Number: 1268807
• Product Code: MIH
• UDI-Device Identifier: 00613994762436
• UDI-Public: 00613994762436
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2017

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: 04/18/2014
• Device Model Number: ENBF3216C145E
• Device Catalogue Number: ENBF3216C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: 83 YR
• Patient Weight: 67