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

Model Number	ETBF3616C145E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Death (1802); Low Blood Pressure/ Hypotension (1914); Rupture (2208)
Date of Event	12/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: etlw1616c82e, serial/lot #: (b)(4), ubd: 06-apr-2016, udi#: (b)(4); product id: etlw1616c124e, serial/lot #: (b)(4), ubd: 05-nov-2016, udi#: (b)(4); product id: etcf3636c49e, serial/lot #: (b)(4), ubd: 06-apr-2016, udi#: (b)(4); product id: etlw1616c93e, serial/lot #: (b)(4), ubd: 10-nov-2018, 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 a 65mm in diameter abdominal aortic aneurysm.At implant, the proximal aortic neck diameter was 20-23-31-36mm and 15mm in length.The neck angulation was 74 degrees.Heli-fx endoanchors were prophylactically implanted during the index procedure.It was reported approximately 4 years post the index procedure the patient presented with abdominal pain and hypotension.Aneurysm rupture was confirmed.Surgical intervention was completed however the patient expired due to the ruptured aortic aneurysm one day post the intervention.Per the investigator the cause of the event was related to the endograft device.
Additional Manufacturer Narrative
Concomitant medical products updated to include the following devices: etlw1610c93es; s/n: (b)(4); use by date: 23-nov-2019; upn # (b)(4).Etlw1616c93e ;s/n: (b)(4); use by date: 02-jan-2018; upn # (b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction to outcomes attributed to adverse event: death and intervention.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Additional Manufacturer Narrative
Updated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 8243521
• Report Number: 2953200-2019-00091
• Device Sequence Number: 16760122
• Product Code: MIH
• UDI-Device Identifier: 00613994991034
• UDI-Public: 00613994991034
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/11/2019

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: 06/24/2016
• Device Model Number: ETBF3616C145E
• Device Catalogue Number: ETBF3616C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2018
• Supplement Date Received by Manufacturer: 01/25/2019; 03/28/2019; 04/11/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 02/12/2019; 04/04/2019; 04/11/2019
• 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; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 56