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

Model Number	ETBF3620C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); Rupture (2208)
Date of Event	05/15/2017
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 ii stent graft system was implanted in a patient for the endovascular treatment of a 60mm diameter abdominal aortic aneurysm.It was reported that the patient presented emergently with back pain.A ct was done and showed there was a ia endoleak and rupture.The physician stated when the stent graft was originally placed they used aptus and placed several endoanchors because the patient had a short and large diameter aortic neck.The stent graft remained where it was originally placed but disease progression moved upward to the level of the renal arteries.The physician snorkeled the right renal and extended using an endurant cuff that was placed just below the level of the sma.The physician stated the cause of the event was anatomy related.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II 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: 6619774
• Report Number: 2953200-2017-00937
• Device Sequence Number: 738827
• Product Code: MIH
• UDI-Device Identifier: 00613994991058
• UDI-Public: 00613994991058
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2017

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: 09/06/2014
• Device Model Number: ETBF3620C145E
• Device Catalogue Number: ETBF3620C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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: 82 YR