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

Model Number	ETBF2316C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: etlw1616c93e, serial/lot #: (b)(4), ubd: 17-jan-2020, udi#: (b)(4).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 56mm diameter abdominal aortic aneurysm.The diameter of the aorta at the renal artery was 17 mm at implant, and the proximal length at implant was 15-20 mm.It was reported that during the index procedure, an unknown type leak was present on angiogram.It is noted to be possibly a type iv or a type iii as per the physician.The physician elected to complete the procedure and follow up in 2 weeks.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Film evaluation summary: the exact source and cause of the endoleak seen during final angiogram could not be determined from the films provided.Two short videos, 11 sec & 14 seconds in length, confirmed widespread contrast blush within the aaa sac.The endoleak appeared to be coming primarily from the left side of the bifurcate just above the level of the flow divider.While a type iii fabric endoleak cannot be ruled out, this appears most likely to 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 likely type iv endoleak.Pending 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: 7361040
• Report Number: 2953200-2018-00403
• Device Sequence Number: 113094
• Product Code: MIH
• UDI-Device Identifier: 00613994991201
• UDI-Public: 00613994991201
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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: 06/08/2018
• Device Model Number: ETBF2316C145E
• Device Catalogue Number: ETBF2316C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 72