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

Model Number	ETEW2828C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/04/2019
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
An endurant stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm and an additional endurant ii stent graft limb etew2828c82e was implanted as a secondary limb extension approximately four years and nine months later.It was reported that follow up ct approximately seven years and nine years later showed a distal type ib endoleak with the right common iliac measuring 31mm.A secondary procedure was carried out and the right internal iliac artery was coiled and a stent graft limb etlw1610c199e placed to the external iliac artery.Final angiogram showed no evidence of a endoleak.As per the physician, the cause of the endoleak was disease progression of the right common iliac artery.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information: it was confirmed that the stent graft limb etew2828c82e was implanted to treat a type ib endoleak.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: 9315532
• Report Number: 9612164-2019-04735
• Device Sequence Number: 468624
• Product Code: MIH
• UDI-Device Identifier: 00613994991416
• UDI-Public: 00613994991416
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 11/29/2019

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: 05/28/2017
• Device Model Number: ETEW2828C82E
• Device Catalogue Number: ETEW2828C82E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 11/29/2019
• 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: 69 YR