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

Model Number	ETLW1613C156E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of a 5.5 cm in diameter abdominal aortic aneurysm.It was reported that the patient returned for routine follow up.The ct revealed a distal type i endoleak.The cause of the event could not be determined.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Films summary review: review of ct¿s from 2 years post-implant ((b)(6) 2017) revealed that an endurant stent graft system had been implanted in the patient.The bifurcate was positioned just below the left renal artery; the bifurcate proximal od measured approximately 27mm and there was approximately 25mm of remaining proximal seal length.The aortic body and infrarenal neck were angulated 35 deg a-p <(><<)>(><(>&<)><(><<)>)> 30 deg lt-rt; relative to the distal aorta.The bifurcate ipsi limb was positioned down into the distal portion of the right common iliac artery; the right limb od measured approximately 17mm.The contra gate opened on the left side, and the contra limb was positioned within the gate overlapping approximately 35mm; markers aligned.The distal contra limb was positioned into the distal portion of the left common iliac artery.The distal 2 cm¿s of the contra limb were acutely angulated approximately 90 deg laterally, and the distal od measured approximately 14mm.Contrast was seen outside the distal contra limb; there appeared to be lack of distal limb radial apposition beginning just distal to the acute bend where the left iliac vessel diameter measured approximately 18mm.However, no clear distal type i endoleak was seen within the aaa, so unclear if the sac was being pressurized via the left limb as there appeared to be adequate seal length.The max diameter aaa measured 64mm, and contrast was also seen along the right side of the contra limb.The area of contrast was seen from the level of the gate ring down into the distal sac.Both limbs were patent.Other than a minor compression at the distal contra/left limb, no stent graft kinks/compression was observed.The exact cause of the reported distal type i endoleak could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant films were not available for comparison.Films returned from 2 years post-implant showed a possible distal type i endoleak from the left contra limb.There appeared to be lack of distal limb radial apposition, possibly due to disease progression and/or morphology changes, beginning just distal to the acute bend where the left iliac vessel diameter measured approximately 18mm.However, it is unclear if the aaa sac was being pressurized via the left limb as there appeared to be adequate seal length between the sac and the dilated distal iliac.Contrast was seen in the aaa sac along the right side of the contra limb from the level of the gate ring down into the distal sac, which appeared most likely to be from a type iii fabric endoleak.Analysis of the returned films did not reveal any stent graft characteristics that could explain this potential type iiib endoleak.The limbs were essentially straight within the aaa sac, and the contra limb was not opposed to the calcified aaa wall as it coursed distally into the iliac.The observed calcified distal aorta was a possible source of abrasion which may have led to this 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: 6899936
• Report Number: 2953200-2017-01509
• Device Sequence Number: 11058181
• Product Code: MIH
• UDI-Device Identifier: 00643169467583
• UDI-Public: 00643169467583
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2017

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: 08/11/2017
• Device Model Number: ETLW1613C156E
• Device Catalogue Number: ETLW1613C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR