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

Model Number	ETLW1620C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	06/20/2018
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 ii stent graft system was implanted in a patient for the endovascular treatment of a 77mm diameter abdominal aortic aneurysm.It was reported that during a ct scan approximately three years later a type ib was discovered in the left common iliac artery.No additional clinical sequelae were reported, and the patient will be monitored.
Additional Manufacturer Narrative
Additional information received: an intervention procedure was completed approximately six weeks after the type ib endoleak was observed, to resolve the distal enlargement of the iliac artery and type ib endoleak.Per the physician the cause of the event is unknown.Film analysis summary: the cause of the distal type i endoleak could not be determined from the films provided.Pre-implant ct¿s were returned.The films were non-contrast; therefore, the measurements were approximate, and no vessel patency or thrombus assessment could be performed.The patient was found to have a 6cm max diameter infrarenal aaa.The proximal neck infrarenal angulation measured ~40 deg a-p x 60 deg lt-rt, and the iliac arteries were moderately tortuous and calcified bilaterally.The approximate left common iliac diameter ranged from 16 ¿ 17mm.Review of post-implant ct¿s revealed that the max diameter aaa had expanded to 75mm, and contrast was seen within the distal aaa sac and along the distal 1 ¿ 2 cm length of the limb extension from a likely type ib endoleak due to insufficient stent graft apposition.The left limb distal od measured 20mm and the left iliac artery diameter at that location was ~25mm.Although pre-implant films were non-contrast, and images during implant & earlier post-implant films were not available for comparison, it appears most likely that the cause of the distal type i endoleak and resulting aaa expansion was due to disease progression; iliac artery dilatation.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7706005
• Report Number: 2953200-2018-01074
• Device Sequence Number: 11039754
• Product Code: MIH
• UDI-Device Identifier: 00613994991621
• UDI-Public: 00613994991621
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2016
• Device Model Number: ETLW1620C82E
• Device Catalogue Number: ETLW1620C82E
• Device Lot Number: V05904429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 08/08/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/23/2018; 10/03/2018
• 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: 68 YR