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

Model Number	ETCF3232C49E
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii aortic extension stent graft was implanted during a chevar procedure for the treatment of an 84mm x 80mm abdominal aortic aneurysm and type ia endoleak.It was reported during the index procedure that the device deployed as normal, the device was advanced and back wheel was closed, the delivery system was pulled below the supra renal fixation and the physician re-made the delivery system by doing the grey to blue motion.At that time it was noticed that the back wheel had popped off device.Upon removal of device, the physicians had a hard time removing the delivery system. once the delivery system was removed it was noted that the tapered tip had come detached and was still in the patient body.At that time the physician made the decision to do a cut down on the femoral artery to remove the tapered tip and repair the artery.As per the physician the cause of the event was due to the patient having previous repairs in the femoral artery, calcified anatomy and the patients advanced age was also noted.No additional clinical sequalae was provided and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii aortic extension stent graft was implanted during a chevar procedure for the treatment of an 84mm x 80mm abdominal aortic aneurysm and type ia endoleak.It was reported during the index procedure that the device deployed as normal, the device was advanced and back wheel was closed, the delivery system was pulled below the supra renal fixation and the physician re-made the delivery system by doing the grey to blue motion.At that time it was noticed that the back wheel had popped off device.Upon removal of device, the physicians had a hard time removing the delivery system. once the delivery system was removed it was noted that the tapered tip had come detached and was still in the patient body.At that time the physician made the decision to do a cut down on the femoral artery to remove the tapered tip and repair the artery.As per the physician the cause of the event was due to the patient having previous repairs in the femoral artery, calcified anatomy and the patients advanced age was also noted.No additional clinical sequalae was provided and the patient is fine.
Additional Manufacturer Narrative
B5; additional information received ; it was confirmed the aortic extension was treating a type ia endoleak that was present on a non mdt stent graft.Product analysis conclusion: the reported difficulty to remove and tapered tip detachment could not be confirmed on the films provided ; therefore, the cause of the events could not be determined.Procedural angiograms showing attempts to remove the delivery system and tip detachment were not received for thorough analysis of the events.However, it is likely that anatomical considerations and disease progression may have contributed to the reported events.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.
Additional Manufacturer Narrative
Product analysis conclusion; the delivery system was received following initial analysis in the santa ana lab.The back-end wheel components were detached with one (1) tab broken.The taper tip was detached and dissected longitudinally.Visual inspection confirmed the hypotube collar had been positioned correctly so that the void formed by the collar during the moulding process was the correct length when compared to a controlled unit.Taper tip material was visible on the hypotube collar.The reported tip detachment was confirmed through analysis.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 EXTENSION CUFF
• Common Device Name: 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: 13188946
• Report Number: 9612164-2022-00092
• Device Sequence Number: 11810281
• Product Code: MIH
• UDI-Device Identifier: 00613994991454
• UDI-Public: 00613994991454
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2023
• Device Model Number: ETCF3232C49E
• Device Catalogue Number: ETCF3232C49E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 01/07/2022; 03/08/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/01/2022; 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male