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

Model Number ETBF3616C145EE

Device Problem Leak/Splash (1354)

Patient Problems Hematoma (1884); Renal Failure (2041); Rupture (2208); Obstruction/Occlusion (2422); Multiple Organ Failure (3261); Unspecified Tissue Injury (4559)

Event Date 11/04/2022

Event Type  Death  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e tlw1616c124ee, serial/lot #: (b)(6), ubd: 26-may-2024, udi#: (b)(4) ; product id: etlw1616c93ee, serial/lot #: (b)(6), ubd: 13-jul-2024, udi#: (b)(4) ; product id: etlw1616c124ee, serial/lot #: (b)(6), ubd: 17-nov-2023, udi#: (b)(4).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.

Event Description

An endurant iis stent graft system was implanted during chevar as part of the enchant study.It was reported from the day of the index procedure until patient discharge 6 days later, the patient had an increase in serum creatinine values determining chronic renal insufficiency re-exacerbation.It was also reported that the patient had complications with the access site which required vascular surgical intervention.An unknown type endoleak observed during imaging prior to discharge.It was further reported the patient suffered a probable aneurysm rupture and death post discharge on an unknown date.The sponsor assessed the post operative complications and death as possible procedural related.No additional sequelae were reported and the patients is expired.

Manufacturer Narrative

Additional information received: it was reported 1 day post the index procedure a left common femoral artery occlusion occurred due to the occluder system used during the chevar.Surgical removal of thrombus and dissected plaque with patch placement was performed.An extended hematoma found in the l subcutaneous tissue of the left lateral wall of the thoracic-abdominal region was also diagnosed 1 day post procedure.A blood transfusion was given and prolonged hospitization required.The hematoma was reported as resolved 5 days post the procedure.2 days post the procedure the patient suffered re-exacerbation of chronic renal failure due to contrast used.Medication and prolonged hospitalization was required.The reported post procedure endoleak was considered to be a gutter endoleak which did not require any further intervention.It was reported 3 days post the index procedure the patient suffered decompensation of general health conditions and worsening existing co morbidities.During hospitalisation, multi organ failure due to worsening of pre existing comorbidities and of cardiac, hepatic, renal and neurologic functionality.In this condition the patient self discharged against medical opinion and at home the suspension of sub-intensive medication could further worsen heath conditions.While the exact date of death is unknown it is hypnotized that it occurred 24-48 hours maximum post discharge.The site assessed the common femoral artery occlusion, hematoma as having a causal relationship to the procedure and not device related.The site assessed the endoleak as possible related to the procedure and not device related.The site assessed the multi-organ failure that led to death as probable related to the procedure and not device related.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.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.

Manufacturer Narrative

Additional information received: the post procedural endoleak was reported as a type iiic.The site updated the assessment of multi-organ failure that led to death as not procedure related.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 II 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: 18363235
• MDR Text Key: 330976664
• Report Number: 9612164-2023-06091
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: ETBF3616C145EE
• Device Catalogue Number: ETBF3616C145EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/24/2024; 04/04/2024
• Supplement Dates FDA Received: 01/25/2024; 04/10/2024
• Date Device Manufactured: 03/10/2022
• 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
• Patient Age: 83 YR
• Patient Sex: Male