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

Model Number	ETUF2314C102E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/24/2019
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 aui stent graft system was implanted in patient for endovascular treatment of a 50 mm abdominal aortic aneurysm.Calcification was noted.It was reported during the index procedure after the aui stent and extension limb was deployed successfully the final angiogram identified a significant type ia or type iii endoleak.As there was some room to extend an aortic cuff was deployed.A repeat angiogram was performed however the endoleak was still present with no improvement noted.A reliant balloon was then inflated in the proximal attachment with the pigtail in the body of the graft.Another angiogram was completed which confirmed the endoleak was a type iiib.A 24 mm limb extension was used to bridge the proximal attachment to the limb excluding the suspect area of the type iiib endoleak.Per the physician the cause of the type iiib endoleak cannot be determined but commented that there appeared to be a breach in the mid graft body that the calcified anatomy may have contributed to.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported endoleak seen immediately following implant was confirmed; however, the exact cause/source of the endoleak could not be determined from the still films returned.Lack of returned cines did not allow for a comprehensive assessment of the endoleak.Analysis of the returned films did not reveal any out of specification stent graft integrity issues.A type iii fabric endoleak cannot be ruled out; this may have been caused by implanting within calcified anatomy.This may also have been an acute type iv blush endoleak caused by fabric porosity.Other factors such as heparin dose, outflow resistance, and volume of the aneurysm sac may have also contributed to this possible type iv endoleak.Additional information: the proximal aortic neck diameter measured 18mm with a length of 49mm.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9138808
• Report Number: 9612164-2019-04163
• Device Sequence Number: 11524635
• Product Code: MIH
• UDI-Device Identifier: 00643169232556
• UDI-Public: 00643169232556
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 11/05/2019

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: 02/27/2021
• Device Model Number: ETUF2314C102E
• Device Catalogue Number: ETUF2314C102E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/05/2019
• 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: 69 YR