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

Model Number ESBF2814C103E

Device Problems Leak/Splash (1354); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 11/06/2023

Event Type  Injury  

Event Description

Heli-fx endoanchors were implanted in an endurant iis graft esbf2814c103.During the endovascular treatment of an abdominal aortic ane urysm.It was noted that the patient had a high torque and tortuous anatomy with a short, angled neck.The endoanchors were being implanted prophylactically due to the patients hostile aortic neck it was reported that during the index procedure, when implanting the 5 endoachor, the enoanchor's position was reviewed at stage 1 and the physician was happy to proceed.At stage stage 2 when deploying the endoachor the endoachor began deploying then popped rolling sideways.It was suspected that the broken endoachor lifted the stent graft causing a type ia endoleak.Once the type ia endoleak was noted, 4 additional endoanchors were added to try to correct the issue and 2-3 endoranchors can be seen around the broken anchor.The endoachor was suspected to be securely stuck between the grafts and vessel wall.The other broken part of the endoanchor was successfully removed from the patient.Per the physician the cause of the endoanchor fracture and type ia endoleak is undetermined.However, the patient¿s anatomy was tortuous with a very hostile neck, and the broken endoanchor may have lifted the graft causing a type ia endoleak.No additional clinical sequelae were reported, and the patient will be monitored.

Manufacturer Narrative

Film evaluation summary: the reported fractured endoanchor and type ia endoleak were confirmed on the films provided, but the cause of these events could not be determined.Full procedural angiograms showing attempts to deploy the endoanchor were not received for a thorough analysis of the event.Pre-implant ct¿s were not available for review and a comprehensive assessment of the patient¿s anatomy could not be performed.Possible anatomical causes of the anchor fracture include implanting into areas of calcification, thrombus, and highly angulated anatomy.In addition, improper apposition, excessive catheter torque build-up, engaging multiple fabric layers, and excessive unsupported applier can contribute to an endoanchor fracture.It is possible the type ia endoleak was caused by the fractured endoanchor lifting the graft fabric as what was reported, but this could not be confirmed.The reported short and angulated aortic neck could also have contributed to the type ia endoleak.Analysis of the returned images did not reveal any out of specification stent graft integrity issues.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 IIS 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: 18275005
• MDR Text Key: 329840200
• Report Number: 9612164-2023-05808
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESBF2814C103E
• Device Catalogue Number: ESBF2814C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2023
• 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): Other
• Patient Age: 70 YR
• Patient Sex: Female