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

Model Number	ENBF2513C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: enlw1616c124e, serial/lot #: (b)(4), ubd: 22-jan-2014, 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 58mm abdominal aortic aneurysm.It was reported that a type ib endoleak was observed on the left ipsilateral side and right contralateral side following examination of a ct scan.The cause of the event is unknown.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Additional information was received for this case.An intervention procedure was carried out on the patient.A plug was placed in the patients right hypogastric on (b)(6) 2018 and the left limb was extended with a 16x16x19 device (serial no.(b)(4)) into the left hypogastric approximately 6 years post the index procedure.Six endoanchors were also implanted in the neck of the graft.No endoleak was visible at the end of the procedure.No additional clinical sequelae were reported and the patient is fine.Film summary evaluation the exact cause of the reported bilateral type ib endoleak could not be determined from the limited films provided.Complete ct prior to implant and at the event were not available, and a thorough assessment of the reported endoleak(s) could not be performed.Review of a pre-implant sizing worksheet revealed that the patient had a 58mm diameter infrarenal aaa.The proximal neck diameter ranged from 21 ¿ 23mm along a 30mm length, and there was moderate neck angulation in the rt-anterior orientation.The right common iliac artery ranged from 12 ¿ 13mm in diameter along a 60 mm length, the left common iliac ranged from 11 ¿ 12mm in diameter along a 85mm length, and no calcification was observed within either iliac artery.Review of a post-implant ct film report revealed that the maximum aaa diameter had increased to 63mm and there was contrast seen within the sac; however, the exact source of the contrast could not be determined.There was also contrast observed around the distal end of the right/contra limb, which measured ~14mm in diameter, and a cross-section of the left common iliac artery distal to the left limb had increased and currently measured 15mm in diameter.It is possible that disease progression, iliac artery dilatation, may have contributed to the reported bilateral type ib endoleaks.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: 7472029
• Report Number: 2953200-2018-00627
• Device Sequence Number: 19140798
• Product Code: MIH
• UDI-Device Identifier: 00613994762252
• UDI-Public: 00613994762252
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 01/16/2014
• Device Model Number: ENBF2513C166E
• Device Catalogue Number: ENBF2513C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/21/2018
• 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: 73 YR
• Patient Weight: 95