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

Model Number	ETBF3216C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
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 ii stent graft system was implanted in a patient for the endovascular treatment of a 65mm diameter abdominal aortic aneurysm.The pre-op images demonstrated a possible focal dissection or pseudoaneurysm at the level of the renal arteries.It was reported approximately 2 years post the index procedure on follow up ct, a type ia endoleak was identified.Contrast was identified outside the most proximal portion of the stent graft however there was no contrast in the sac of the aneurysm.While the physician had concerns the current filling defect observed was related to the pre-op suspected dissection it has been noted that there is no risk currently posed to the patient with no intervention planned.The cause of the event is undetermined.No additional clinical sequelae were reported, and the patient is will be monitored.
Additional Manufacturer Narrative
Film evaluation summary; the exact cause of the reported proximal type i endoleak could not be determined from the films provided.The anatomy at implant is unknown, angiograms during implant were not available, and earlier post-implant films were not provided.The cause of the outpouched aorta observed near the level of the renal arteries could not be determined; it is possible that this was a pre-existing condition or disease progression may have led to this event.It is also unclear if this finding may have led to any increase in the size of the aaa which appears to have remained at 65mm since implant, or, if this outpouching may be pressurizing the aaa sac.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: 7946335
• Report Number: 2953200-2018-01437
• Device Sequence Number: 1343696
• Product Code: MIH
• UDI-Device Identifier: 00613994990983
• UDI-Public: 00613994990983
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: 04/30/2017
• Device Model Number: ETBF3216C145E
• Device Catalogue Number: ETBF3216C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR