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

Model Number	ETBF3216C145E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Dementia (1808); Low Blood Pressure/ Hypotension (1914); Occlusion (1984)
Date of Event	10/17/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: enlw1613c93e, serial/lot #: (b)(4), ubd: 12-mar-2014, udi#: (b)(4); product id: etlw1624c93e, serial/lot #: (b)(4), ubd: 15-aug-2014, udi#: (b)(4).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 an abdominal aortic aneurysm of unknown size.It was reported that the patients¿ daughter contacted technical services approx.6 years post index procedure and stated that the patients ¿leg stents¿ initially failed and an additional procedure was performed to correct the issue.The patients¿ daughter also stated that she believes the stent grafts caused dementia in her father.Per the physician the index procedure was successful with an exceptional final result.Post the index procedure the incorrect hypertensive medications were administered which led to severe hypotension and a hypercoagulable state.It was also reported the patient had a cardiopulmonary arrest.The patient developed bi-lateral limb thrombosis from low blood pressure.The physician performed a bi-lateral thrombectomies to clear the clots.An angioplasty was also completed with the external and common iliacs including the right external iliac stented.The patients thrombosed limbs were opened and flow was restored.The patient was discharged and 2 post up cts showed favorable clinical status.This patient was lost to follow up 2 years post index procedure.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7825860
• Report Number: 2953200-2018-01237
• Device Sequence Number: 1517601
• Product Code: MIH
• UDI-Device Identifier: 00613994990983
• UDI-Public: 00613994990983
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2014
• Device Model Number: ETBF3216C145E
• Device Catalogue Number: ETBF3216C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 11/22/2018
• 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