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

Model Number	ENBF3616C166E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Aneurysm (1708); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
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 a 55 mm abdominal aortic aneurysm.It was reported that a ct scan carried out 7 years later showed the bifurcated stent graft had migrated about 1cm, the aneurysm had increased and the neck dilated until the aneurysm started just below the lowest renal.A large type ia endoleak was also observed on the posterior aspect of the aorta just below the left renal.The physician attributed the cause of the event to neck dilation causing migration and endoleak.The event has not resolved.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Film evaluation summary: the cause of the stent graft migration, leading to the proximal type i endoleak and aaa expansion, appears most likely to have been caused by disease progression.Review of a pre-implant sizing worksheet showed that the patient had a short and conical-shaped proximal neck, ranging in diameter from 29 ¿ 34mm along a 12mm length.The neck was noted to be moderately angulated, with mild calcification and thrombus.Review of a 3d/ct film report from ~7 years post-implant revealed that the aaa had increased to 72mm in diameter, the stent graft had migrated distally 10mm, and there was a proximal type i endoleak.The proximal neck diameter just below the lowest left renal had increased to 41mm, 10mm lower was 56mm in diameter, and the neck contained severe thrombus.Along the 15mm suprarenal neck beginning just above the right renal, the diameter ranged from 32 ¿ 35mm.Disease progression (neck dilatation) of the short and conical-shaped proximal neck likely caused the stent graft migration leading to the proximal type i endoleak.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT 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: 7568426
• Report Number: 2953200-2018-00806
• Device Sequence Number: 1758768
• Product Code: MIH
• UDI-Device Identifier: 00613994762375
• UDI-Public: 00613994762375
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2013
• Device Model Number: ENBF3616C166E
• Device Catalogue Number: ENBF3616C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR