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

Model Number	ETCF3636C49E
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in the patient for the endovascular treatment of a 55 mm abdominal aortic aneurysm.It was reported that during the index procedure, the device was implanted, where an endoleak type 1a was noted after ballooning.The physician then decided to implant an aortic cuff.It was stated that when the physician attempted to advance delivery system to recapture tip, the distal portion of cuff appeared to fold in on itself, which was unable to be opened endovascularly, so decision was made to convert to open surgery.It was reported that the surgeon clamped aorta below the right renal artery and cut out part of the stent graft, and proceeded with aorto-aorto tube graft.The device was explanted partially.After surgery, the patient was transferred to icu and died on the next day.As per the physician, cause of the event was that the distal graft did not fully open after unsheathing.The physician stated that part of the graft was not open or got caught on the delivery system as it was advanced proximally to recapture tip.No additional clinical sequalae were reported and the patient expired.
Additional Manufacturer Narrative
B5.Additional information received;it was reported the ettf3636c49e cuff was partially explanted, the fabric was removed, but suprarenal stents were not.The esbf3614c103e was also partially explanted but the limbs were left.It was reported the cause of the type ia and the cause of death could not be determined per the physician 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.

• 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
• MDR Report Key: 11894755
• Report Number: 9612164-2021-02095
• Device Sequence Number: 3633732
• Product Code: MIH
• UDI-Device Identifier: 00613994991461
• UDI-Public: 00613994991461
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 02/16/2023
• Device Model Number: ETCF3636C49E
• Device Catalogue Number: ETCF3636C49E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 82 YR