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

Model Number	ETBF2513C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
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 ii stent graft system was implanted in a patient for the endovascular treatment of a 54 mm diameter abdominal aortic aneurysm.It was reported that during the one month follow up scan a type ia endoleak was noted.As per the physician, the cause of the event is patient anatomy related, due to the diameter of aorta where the supra-renal stent sits and stent graft angulation in the aortic neck.No additional clinical sequelae were reported and the patient is will be monitored.
Additional Manufacturer Narrative
Film evaluation summary the cause of the reported proximal type i endoleak could not be determined from the pre-implant film report provided.Images during implant were not available for return and the reported event could not be assessed.Post-implant ct¿s were also not provided and the in-vivo stent graft configuration could not be evaluated.The pre-implant report revealed that the patient¿s proximal neck just below the renal arteries was of small caliber; 18mm diameter.Therefore, it is possible that stent graft oversizing, implant of the 25mm bifurcate into the small and calcified neck, may have contributed to the type ia endoleak.The reported neck angulation may have also been a factor.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: sizing information was provided.The proximal aortic neck diameter measured 18-22mm with a neck length of 15mm.Mild calcification and thrombus was noted at the proximal neck.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: 8979101
• Report Number: 9612164-2019-03821
• Device Sequence Number: 3380525
• Product Code: MIH
• UDI-Device Identifier: 00613994991225
• UDI-Public: 00613994991225
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2019

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: 04/02/2021
• Device Model Number: ETBF2513C124E
• Device Catalogue Number: ETBF2513C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 09/17/2019; 10/11/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/11/2019; 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR