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

Model Number	ETLW1613C93E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 50mm diameter abdominal aortic aneurysm.It was reported that a ct exam performed approximately 2 years post implant, the patients right iliac artery diameter measured between 12.7-13mm.The ct exam also revealed a type ib endoleak on the right side.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 the physician.
Additional Manufacturer Narrative
Additional information received on this case reported that a re-intervention to treat the type 1b endoleak was carried out approximately 2 months post index procedure.It was reported that during the intervention the patient had a 16x16x82 limb placed in the right common iliac artery to the level of the internal/external iliac artery bifurcation.During the final imaging run there were no endoleaks observed and the physician stated that he was satisfied with the outcome of the procedure.No additional clinical sequelae were reported and the patient is fine film evaluation summary; the distal type i endoleak and resulting aaa expansion appears to be due to an inadequate distal right iliac seal; however the exact cause could not be determined.Pre-implant films revealed that the neck diameter ranged from 18 ¿ 15mm along the 3cm length, and was severely angulated ~70 deg lt-rt relative to the distal aorta.The iliac arteries were tortuous and contained thrombus calcification, and the right common iliac artery was aneurysmal at its mid-length ranging in diameter from 10 ¿ 16 ¿ 12mm.Films at implant and earlier post-implant images were not available for return.Ct¿s returned from 23 months post-implant revealed that the aaa max diameter had increased from 49 to 58mm, and the bifurcate aortic body was angulated ~80 deg lt-rt relative to the right/contra limb.The contra limb crossed over the ipsi limb, and was positioned into the mid-length aneurysmal section of the right common iliac artery.Contrast was seen from the right limb which appeared to be from a distal type i endoleak.Within the rcia there was contrast outside the 14mm diameter distal stent ring which appeared unopposed to the vessel and measured ~17mm in diameter.It appears likely that continued disease progression within the calcified and aneurysmal right common iliac artery likely contributed to the insufficient right limb seal.Images immediately post-implant were not available, however, potential morphology changes with increasing limb angulation and possible limb migration may have also contributed to the distal type i endoleak.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: 7159517
• Report Number: 2953200-2018-00003
• Device Sequence Number: 64263
• Product Code: MIH
• UDI-Device Identifier: 00613994991539
• UDI-Public: 00613994991539
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 01/25/2018

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: 09/01/2016
• Device Model Number: ETLW1613C93E
• Device Catalogue Number: ETLW1613C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 01/25/2018
• 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: 80 YR