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

Model Number	ETLW1616C199E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	10/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A talent stent graft system was implanted in a patient for the endovascular treatment of a 60mm diameter abdominal aortic aneurysm on.Endurant stent grafts were implanted during a secondary procedure for an unknown reason on (b)(6) 2015.Currently the vessels are severely tortuous and moderately calcified.It was reported that the patient presented emergently approximately 8 years post index procedure and approximately 2 years post secondary procedure with symptoms of a ruptured aneurysm.A type iii endoleak was identified where the contralateral limb pulled out of the contralateral gate (left) of the original talent bifurcated stent.A 14x16x105 talent limb was identified as the contralateral limb.The 16x16x199 endurant limb was identified as the device that pulled out along with the 14x16x105 talent limb.The endurant limb was used in a previous unknown secondary intervention to reline the stent graft.The physician implanted a 36mm endurant aui and 16x16x156 endurant limb from the left side to bridge into the existing system followed by a fem-fem bypass with another manufacturer plug placed in the right common iliac artery to occlude it.Post angio showed continued type iii endoleak.At this time, a 36mm endurant aortic cuff was advanced through the 36mm aui and implanted to the level of the renal arteries.Ballooned with reliant and again angio showed continued type iii enoleak.A second 36mm endurant aui was advanced through the existing aui and cuff at the level of the renal arteries and was deployed and ballooned.Final angio show that the endoleak was resolved.Per the physician the cause of the event is due to anatomy (aortic remodeling and tortuosity).No additional clinical sequelae were reported and the patient is fine.

• 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: 7040088
• Report Number: 2953200-2017-01805
• Device Sequence Number: 2144161
• Product Code: MIH
• UDI-Device Identifier: 00643169467651
• UDI-Public: 00643169467651
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 11/17/2017

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: 01/04/2017
• Device Model Number: ETLW1616C199E
• Device Catalogue Number: ETLW1616C199E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/17/2017
• 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