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

Model Number	ETBF3220C166E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: other relevant device(s) are: product id: etlw1620c124e, serial/lot #: (b)(4), ubd: 09/24/2016, udi#: (b)(4).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 an abdominal aortic aneurysm.It was reported the patient phoned technical services and reported a back x-ray taken approximately 3 years 10 months post implant has identified a bulge within the stent graft.

• 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: 8486085
• Report Number: 2953200-2019-00447
• Device Sequence Number: 2672152
• Product Code: MIH
• UDI-Device Identifier: 00613994991027
• UDI-Public: 00613994991027
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2016
• Device Model Number: ETBF3220C166E
• Device Catalogue Number: ETBF3220C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR