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

Model Number	ETBF3616C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/12/2018
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
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 50mm diameter abdominal aortic aneurysm with short neck indication.It was also reported that endoanchors were implanted on an unknown date post the index procedure.It was reported that approximately four years post-index procedure a follow up ct revealed a moderate type ia endoleak and it was reported the aneurysm was up to 2mm below the level of the lowest renal artery.Per the physician the cause of the event was anatomy related due to disease progression with neck dilation.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
The reported proximal type i endoleak was confirmed.However, the exact cause of the type ia endoleak leading to the aaa enlargement could not be determined from the films provided.The anatomy at implant is unknown, and earlier follow-up films were not provided for comparison.Review of a post-implant ct-3d film report from 4 years post-implant (b)(6) 2018) revealed that the aaa diameter measured 81mm and there was a proximal type i endoleak.The bifurcate was positioned just below the renal arteries within the short and conical-shaped neck, and multiple endoanchors appeared to have been implanted into the bifurcate proximal margin.The neck diameter just below the renals measured 28mm, 15mm below the renals tapered out to 36mm in diameter, and the infrarenal neck contained thrombus.The bifurcate ipsi limb was seen extending distally into the left common iliac, and the contra limb was positioned down into the right common iliac artery.The devices appeared patent and no other obvious issues were observed.It is possible that disease progression, leading to the short and dilatated proximal neck, may have contributed to the proximal type i endoleak.Additional information received; the endoanchors were implanted at approximately the same time as the endurant.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: 8084387
• Report Number: 2953200-2018-01587
• Device Sequence Number: 2165689
• Product Code: MIH
• UDI-Device Identifier: 00613994991034
• UDI-Public: 00613994991034
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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: 09/03/2016
• Device Model Number: ETBF3616C145E
• Device Catalogue Number: ETBF3616C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/18/2018
• 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: 85 YR