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

Model Number ESBF2314C103E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Numbness (2415); Obstruction/Occlusion (2422)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: e tlw1616c124e, serial/lot #: (b)(4), ubd: 23-mar-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Endurant stent grafts etuf2314c102, etlw1616c146e and etlw1613c82e were implanted for the treatment of thrombus in the previously implanted esbf2314c103e and etlw1616c124e devices (approximately 3 years previous).A fem fem bypass was also completed during the original index procedure.Approximately 2 years post the original index procedure intervention was completed for thrombus and occlusion and the patient had been on anti-coagulation medication since this time.Approximately 3 years post the original index procedure the patient presented with right leg pain and angiogram showed evidence of thrombus within the previously implanted esbf2314c103e and etlw1616c124e devices and etuf2314c102, etlw1616c146e and etlw1613c82e were implanted.Thrombectomy was performed on the same day, the esbf2314c103e and etlw1616c124e were re-lined with an etuf2314c102 and etlw1616c146e with the placement of an etlw1613c82e to extend into the external right iliac.Thrombectomy was also performed on the previous femoral-femoral bypass and femoral-popliteal bypass.During the angiogram post implant of the etuf2314c102e it was noted that the left renal artery appeared to be occluded, thrombectomy was performed with implantation of a covered balloon expandable stent.Angiogram then revealed flow in the left renal artery.Per the physician, the thrombus development was possible due to an outflow issue in the femoral-popliteal bypass and femoral-femoral bypass.It was reported the cause of the renal artery occlusion was due to thrombus from the aorta which embolized to the left renal during the implant of the endurant aui or during post implant ballooning.No additional clinical sequalae were reported and the patient is fine.

Manufacturer Narrative

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 IIS BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 12405536
• MDR Text Key: 269632620
• Report Number: 9612164-2021-03364
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439993
• UDI-Public: 00643169439993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2020
• Device Model Number: ESBF2314C103E
• Device Catalogue Number: ESBF2314C103E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 11/04/2021
• Supplement Dates FDA Received: 11/08/2021
• Date Device Manufactured: 02/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 49 YR
• Patient Sex: Male