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

Model Number	ETLW1610C93E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Injury (2348)
Date of Event	09/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: etuf2814c102e, serial/lot #: (b)(4), ubd: 10-jul-2016, 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 60mm diameter abdominal aortic aneurysm.It was reported that during follow up, over two years later, a ct identified aneurysm enlargement (from 50mm to 60mm) without an endoleak.It was reported that the physician performed open repair on the patient and explanted the stent grafts.Per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Explant evaluation summary; from the examination of the returned devices and clinical information provided, the exact cause of the aaa expansion could not be determined.The patient¿s anatomy is unknown and films were not available for review.Therefore, assessment of the stent graft in-vivo configuration during the implant duration, including the amount of aui/limb extension overlap, could not be performed.Although it is possible that the three (3) fabric holes observed in the iliac limb may have been the source of a type iii fabric endoleak which contributed to the aaa expansion, no endoleak was reported via films and no blood was found in the aaa sac during the explant.It is also possible that these holes may have been covered by tissue/thrombus or by the overlapping aui.It is possible that endotension and/or infection, as indicated by the reported appearance of white puss in the sac and a probable hygroma, may have led to the aaa expansion.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7922304
• Report Number: 2953200-2018-01365
• Device Sequence Number: 13873869
• Product Code: MIH
• UDI-Device Identifier: 00643169467606
• UDI-Public: 00643169467606
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2017
• Device Model Number: ETLW1610C93E
• Device Catalogue Number: ETLW1610C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 12/19/2018
• 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: 76 YR