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

Model Number	ETLW1613C156E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	01/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are product id: etlw1616c93e, serial/lot #: (b)(4), ubd: 19-jul-2017, udi#: (b)(4); product id: esbf3214c103ee, serial/lot #: (b)(4), ubd: 06-dec-2017, 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 that the patient presented emergently approximately three years later with a rupture.Ct showed a type iii endoleak and another endurant ii stent graft limb etlw1616c124e was implanted to seal the separation of the original stent graft.Angiography showed the endoleak was resolved.It was reported that the stent graft limb had separated from the main stent graft body and this led to the rupture.As per the physician the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.

• 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: 9562354
• Report Number: 9612164-2020-00123
• Device Sequence Number: 16693715
• Product Code: MIH
• UDI-Device Identifier: 00643169467583
• UDI-Public: 00643169467583
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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: 11/23/2017
• Device Model Number: ETLW1613C156E
• Device Catalogue Number: ETLW1613C156E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/08/2020
• 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: 74 YR