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

Model Number	ETBF2813C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/17/2019
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 abdominal aortic aneurysm.It was reported that approximately 7 years and 2 months post index procedure the patient¿s follow up ct showed that the patient¿s right common iliac artery had enlarged to approximately 90mm and it appeared to be leaking though the limb of the bifurcated stent graft.The patient was brought to the or and angiograms showed the right limb was leaking contrast.The endoleak was confirmed to be a type iii fabric.The physician decided to place an additional stent graft limb where the leak was occurring and final angio showed that the endoleak has resolved.As per the physician the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported type iiib endoleak coming from the right limb of the bifurcate, with a resulting increase in the size of the right common iliac artery was confirmed; however, the exact cause could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant ct¿s were not provided for comparison.Analysis of the returned ct¿s from 7 years post-implant showed contrast filling the rcia which appeared to be coming from the bifurcate right/ipsi limb, near to where the limb entered the rcia and was coursing along an area of aortic/iliac vessel calcification.The endoleak appears most likely to have been a type iiib fabric endoleak.Fabric wear due to external abrasion from vessel calcification and/or from adjacent stent(s) abrading the limb near the origin of the rica are potential root causes.Limb angulation with possible aneurysm morphology changes during the implant duration may have also exacerbated the fabric abrasion wear.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: 9611398
• Report Number: 9612164-2020-00362
• Device Sequence Number: 16811612
• Product Code: MIH
• UDI-Device Identifier: 00613994991300
• UDI-Public: 00613994991300
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 09/19/2014
• Device Model Number: ETBF2813C166E
• Device Catalogue Number: ETBF2813C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2019
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/20/2020
• 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: 78 YR