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

Model Number	ETBF2816C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/04/2019
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 ii stent graft system was implanted in a patient for the endovascular treatment of an unknown size abdominal aortic aneurysm.It was reported approximately 3 years post the index procedure the patient presented and an angiogram identified a small type ia endoleak from the top of the graft.The physician elected to implant a cuff and endoanchors to ensure seal and resolve the endoleak.Per the physician the cause of the event was anatomy related and commented that there appeared to be somewhat of a short seal zone and the initial graft appeared to be placed about 5mm under the renal arteries.No additional clinical sequelae were reported and the patient is fine.

• 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: 8403231
• Report Number: 2953200-2019-00347
• Device Sequence Number: 13531298
• Product Code: MIH
• UDI-Device Identifier: 00613994991324
• UDI-Public: 00613994991324
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/08/2019

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: 05/10/2018
• Device Model Number: ETBF2816C145E
• Device Catalogue Number: ETBF2816C145E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/08/2019
• 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: 65 YR