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

Model Number	ETLW1610C93E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A talent aaa stent graft system was implanted for the endovascular treatment of an abdominal aortic aneurysm.Approximately ten years later the patient presented emergently with back pain and a ct scan performed identified contrast in the aneurysm sac with bilateral type ib endoleaks observed.Intervention was completed at this time.On the right side the hypogastric artery was coiled and a limb extension was placed landing on the external iliac (b)(4).After ballooning this area with a reliant balloon it appeared there was a type iii endoleak immediately proximal to this placed device so the right iliac was relined with an additional endurant limb (b)(4).On the left side, an iliac extension was implanted at the left hypogastric and the event resolved.Per the physician the cause of the event was anatomy related due to bilateral iliac dilation affecting seal of both iliac limbs.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
Additional information was received: it was confirmed that the type iii endoleak was between the talent bifurcate and the endurant limb in the external iliac.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8068533
• Report Number: 2953200-2018-01577
• Device Sequence Number: 1557463
• Product Code: MIH
• UDI-Device Identifier: 00643169467606
• UDI-Public: 00643169467606
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2019

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: 07/25/2020
• Device Model Number: ETLW1610C93E
• Device Catalogue Number: ETLW1610C93E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 11/13/2018; 02/06/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/05/2018; 02/20/2019
• 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: 87 YR