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

Model Number ESBF3614C103EJ

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problem Cardiac Arrest (1762)

Event Date 04/08/2024

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: e tlw1616c124ej, serial/lot #: (b)(6), ubd: 28-nov-2025, udi#: (b)(4), product id: etuf3614c102ej, serial/lot #: (b)(6), ubd: 03-jan-2025, udi#: (b)(4), product id: etlw1624c93ej, serial/lot #: (b)(6), ubd: 14-dec-2024, udi#: (b)(4).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank, because the information is currently, unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

An endurant iis stent graft system was implanted, during the emergent endovascular treatment of an abdominal aortic rupture.  it was reported, during the index procedure, after the bifurcate was implanted, an attempt was made to insert etlw1624c93ej on the contralateral side.However, the device failed to advance through the access vessel.The limb was removed and the physician attempted to advance a non-mdt stent.However, this was also unsuccessful, due to the same issue.The physician opted to switch to an aui (etuf3614c102ej), which was successfully implanted without any signs of endoleaks.After the aui was implanted, the abdomen was opened for hematoma removal and a fem bypass.After removal of hematoma, the patient went into cardiac arrest, while undergoing the fem bypass.And the patient expired.Per the physician, the cause of the failure to advance the graft was anatomy related and possible defective access vessel.

Manufacturer Narrative

It was reported the physician did not state that the death was due to the device.It seems that rupture may be the cause, but the details are unknown.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ENDURANT IIS BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 19114240
• MDR Text Key: 340223184
• Report Number: 9612164-2024-01815
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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 Model Number: ESBF3614C103EJ
• Device Catalogue Number: ESBF3614C103EJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/22/2024
• Date Device Manufactured: 06/14/2023
• 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): Death