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	10/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of a 55mm diameter abdominal aortic aneurysm.It was reported that the patient was admitted to the hospital approximately 6 years and 2 months post index procedure with abdominal pain.A ct scan showed that the aneurysm has grown from 5.5 cm to 8.6cm a proximal type i endoleak and a distal type i endoleak was also noted on the right.The left appeared to have a seal.The physician implanted a 36x36x49 endurant cuff proximally and a 16x24x93 endurant right side extension distally.The proximal endoleak has resolved with the cuff placement.The right side extension was placed with a small residual endoleak that was ballooned multiple times.The endoleak improved but the decision was made to have a follow up ct scan after discharge.A retrograde angiogram was done on the left side and no endoleak was visualized.It was reported that the physician confirmed that, post re-intervention, the patient was no longer having abdominal pain or tenderness.Per the physician the event was anatomy related (disease progression).No additional clinical sequelae were reported and the patient fine.

• 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: 7028183
• Report Number: 2953200-2017-01771
• Device Sequence Number: 1184300
• Product Code: MIH
• UDI-Device Identifier: 00613994762436
• UDI-Public: 00613994762436
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

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: 05/29/2013
• Device Model Number: ENBF3216C145E
• Device Catalogue Number: ENBF3216C145E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/14/2017
• 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