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

Model Number	ETBF2816C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: etlw1616c124e, serial/lot #: (b)(4), ubd: 22-oct-2015, udi#: (b)(4); product id: etlw1616c82e, serial/lot #: (b)(4), ubd: 31-oct-2015, 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 unknown diameter abdominal aortic aneurysm.The patient called medtronic technical services to report that approximately 4 years 4 months post implant, the patient had an appointment with their physician, at which an unknown endoleak was seen on an echo.The cause of the event is unknown.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when the patient was evaluated in may by the physician there was no evidence of an endoleak.
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: 8666906
• Report Number: 9612164-2019-02153
• Device Sequence Number: 16696127
• Product Code: MIH
• UDI-Device Identifier: 00613994991133
• UDI-Public: 00613994991133
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2019

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: 10/15/2015
• Device Model Number: ETBF2816C166E
• Device Catalogue Number: ETBF2816C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 06/18/2019; 08/22/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 07/11/2019; 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 79