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

Model Number ETBF3616C145EJ

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

Patient Problems Intimal Dissection (1333); Abdominal Pain (1685); Occlusion (1984); Pain (1994); Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of a 55mm abdominal aortic aneurysm.The procedure completed without any endoleaks.It was reported that under 3 weeks later, a ct scan was performed because the patient had a slight stomach ache.The left renal artery (ra) had a thrombotic occlusion, probably because a dissection occurred near the entrance of the left ra, there was no renal artery embolism found.As per the physician the cause of the event can not be determined.No additional clinical sequelae were provided and the patient will be monitored.

Manufacturer Narrative

Additional information received: intervention was performed, however due to a thrombus obstruction in the lra the attempt to remove the thrombus was unsuccessful.Failed.The patient's was reported as stable and will be continued to be monitored.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
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10762183
• MDR Text Key: 213901803
• Report Number: 9612164-2020-04162
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: ETBF3616C145EJ
• Device Catalogue Number: ETBF3616C145EJ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 11/27/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR