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

Model Number	ETLW1624C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Perforation of Vessels (2135)
Date of Event	06/29/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: etlw1616c124e, serial/lot #: (b)(4), ubd: 08-apr-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii bifurcate stent graft system was implanted in a patient for the endovascular treatment of an 55+ mm abdominal aortic aneurysm.It was reported that at the end of the index procedure, during ballooning of the stent graft the distal or the proximal right iliac artery was ruptured.It was reported that the physician quickly implanted a etlw1616c124e limb from inside the previously implanted etlw1624c124e, across the internal iliac and into the right external artery, where the physician believed to be the disruption.Another angiogram was performed and some rupture was still noted.The physician then decided to implant a etlw1620c156e it the higher and lower end on the previously implanted stent graft.Final angiogram was performed with no additional evidence of ruptured artery.As per the physician, cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
It was reported the patient presented with pain and hypertension on (b)(6) 2020.A ct scan showed some fluid / old blood in abdominal but no definitive rupture was seen.A possible type ii endoleak was observed.It was decided to explant the stent graft system to further explore the cause of the hypertension.A clot was found by the ima which was consistent with the type ii endoleak observed on ct, it was also reported the aorta and iliac were inflamed.A fem-fem bypass was performed but it was noted the hypertension had not been addressed.It was reported the patient received blood in icu due to the hypertension but then later expired.It was reported that the actual site of the rupture was distal to iliac limb and either at iliac bifurcation or in proximal right external but not at the level of iliac limb.The etlw1616c124e and etlw1620c156c were implanted after the rupture occurred to cover and contain it.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.

• 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: 10319401
• Report Number: 9612164-2020-02716
• Device Sequence Number: 14317367
• Product Code: MIH
• UDI-Device Identifier: 00643169467507
• UDI-Public: 00643169467507
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: ETLW1624C124E
• Device Catalogue Number: ETLW1624C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 07/19/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Outcome Attributed to Adverse Event: Death; Other; Required Intervention
• Patient Age: 80 YR