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

Model Number	ETLW1616C82E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Injury (2348)
Date of Event	04/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: information references the main component of the system.Other relevant device(s) are: product id: etlw1628c124e, serial/lot #: (b)(4), ubd: 16-jan-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of a 50mm abdominal aortic aneurysm.It was reported that a ct performed nearly two years after the index procedure, showed a type iii endoleak.As per the physician it is thought that the limb etlw1628c124e has separated from the main body stent graft.It was then confirmed that the stent graft limbs etlw1616c82e and etlw1628c124e had separated.A secondary procedure was carried out five days after the endoleak was noted on ct, and the stent graft limbs etlw1628c156e and etlw1616c82e were implanted as treatment.Follow up ct showed that the endoleak is resolved.As per the physician the cause of the event can not be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
B:5 additional information received; six months following the previous intervention, the patient had a ct performed which showed an internal iliac aneurysm.It was said in the previous intervention procedure, the physician had coiled the left internal iliac at the time but the aneurysm continued to grow since.As a result an endurant limb was implanted on the same date of the ct to cover internal and extend into the external iliac artery.This resolved the event.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 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: 10078037
• Report Number: 9612164-2020-01928
• Device Sequence Number: 11559264
• Product Code: MIH
• UDI-Device Identifier: 00643169467576
• UDI-Public: 00643169467576
• 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: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2020

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: 12/11/2019
• Device Model Number: ETLW1616C82E
• Device Catalogue Number: ETLW1616C82E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 11/27/2020
• 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: 73 YR