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

Model Number ETBF2813C145EE

Device Problem Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); Hypovolemic Shock (1917); Rupture (2208)

Event Date 09/21/2023

Event Type  Death  

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.

Event Description

An endurant ii stent graft and endurant cuff were implanted during the endovascular treatment of a aaa.It was reported during the index procedure the endurant ii stent graft was implanted normally.During the final contrast study a small type ia endoleak was observed.The physician decided to implant an endurant ii aortic cuff.During removal of the delivery system the usual maneuvers were attempted to remove the delivery system however it became blocked in the middle and distal part of the stent graft.The physician rotated the delivery system and managed to remove it however the tapered tip detached and remained inside the patient's body.It was reported the patient expired on an unknown date due to complications post endograft tip rupture.The cause of the type ia endoleak and tip detachment were not provided.

Manufacturer Narrative

B5; additional information was received: sizing was noted as -(neck wide 22mm proximal and 28mm distal, neck length 15mm, ifu angle neck, aneurysm wide (7-8cm).Tortuous access and aortic neck.No calcium was noted.It was reported that the physician used normal force when attempting to remove the delivery system.The physician tried to remove the tip using an endovascular approach before deciding to covert to open surgery.Both grafts were explanted and the tip removed while the patient was still alive.The patient suffered complications post the conversion and expired on the day of the index procedure.The physician was unable to provide a cause of the tip detaching.It was reported the entire tapered tip separated.The physician watched the tapered tip detach under fluoroscopy while the delivery system was being removed.The patient experienced an aortic neck rupture.It was said the delivery system got caught at first in the middle of the stent graft at the flow divider and secondly at the distal iliac branch.It got caught in areas of tortuosity.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.

Manufacturer Narrative

Additional information received: it was reported that the cause of the aortic rupture that occurred in the aortic neck post implant of the stent grafts is unknown.The cause of death was due to hypovolemic shock ( massive hemorrhage) at the level of the proximal neck of the aneurysm.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.

Manufacturer Narrative

Additional information received; it was clarified that the the tapered tip was retrieved without the wire when it was removed via open surgery.The tapered tip was loose through the ascending aorta for a while.The piece separated was entire tapered tip.The anatomy was noted to be tortuous and slightly stenotic.The delivery system became caught due to tortuosity inside the graft first in the middle of the stent graft at the flow divider and secondly at the distal iliac branch.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 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: 17823627
• MDR Text Key: 324322875
• Report Number: 9612164-2023-04372
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup,Followup
• Report Date: 10/05/2023

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 Model Number: ETBF2813C145EE
• Device Catalogue Number: ETBF2813C145EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 10/01/2023; 09/28/2023; 09/28/2023
• Supplement Dates FDA Received: 10/04/2023; 10/05/2023; 10/05/2023
• Date Device Manufactured: 01/17/2023
• 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
• Patient Age: 77 YR
• Patient Sex: Male