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

Model Number	ETLW1628C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Cardiac Arrest (1762); Death (1802); Pain (1994); Rupture (2208)
Date of Event	10/08/2017
Type of Reportable Event	Death
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 the patient for the endovascular treatment of a 55mm abdominal aortic aneurysm.The patient had 3 duplex ultrasounds after the initial implant at 3-month intervals, all showing the aneurysm stable at pre-operative size of 55mm.However, it was reported that duplex ultrasound performed approximately 13 months post index procedure showed aaa growth to 67mm.The physician sent the patient for ct which showed a type 2 leak from the ima.Coiling of the ima was performed approximately 14 months post implantation and resolved the type ii endoleak.A ct performed approximately 18 months post index procedure showed the ima was sealed with no leaks.Further ultrasound performed approximately 24 months post index procedure showed a possible aneurysm enlargement but no leak.It was reported that the patient presented emergently approximately 27 months post index procedure with back pain.While ct was being performed the aneurysm ruptured and the patient arrested and died.The physician believed the death was possibly caused by the aneurysm in the patient's left common iliac that the flared limb was on.The physician believed that the aneurysm had grown and caused a type 1b leak, causing the aaa to expand and rupture.However, the cause could not be conclusively determined.It was reported that the physician believed the cause of death was not device related after reviewing the ct.No additional clinical sequelae were reported.

• 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: 6992655
• Report Number: 2953200-2017-01674
• Device Sequence Number: 1549548
• Product Code: MIH
• UDI-Device Identifier: 00643169467453
• UDI-Public: 00643169467453
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/01/2017

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: 06/07/2017
• Device Model Number: ETLW1628C124E
• Device Catalogue Number: ETLW1628C124E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 66 YR