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

Model Number ESBF2514C103EJ

Device Problems Leak/Splash (1354); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  Injury  

Event Description

An endurant iis stent graft system (esbf2514c103ej) was implanted during the endovascular treatment of a 45 mm abdominal aortic aneurysm.It was reported during the index procedure, following the insertion of the main body through the left approach and deployment of the contralateral gate, an issue arose.The back-end wheel was rotated to deploy the top stent, but the tapered tip of the delivery system did not respond as anticipated and failed to deploy.The physician disassembled the back-end wheel and connected a syringe to the distal end of the delivery system which pushed up the tapered tip, successfully deploying the top stent.The physician did not have to use more force than usual when advancing the delivery system.As the delivery system was being withdrawn, a pull-through was necessary from the proximal side due to the risk of leaving the tapered tip inside the patient.The distal end of the guidewire that was passed through entered the distal end of the delivery system, so the area where the back-end wheel was located was further disassembled and cut off to expose the wire.The front grip, screw gear, and tapered tip were subsequently removed.It was confirmed the tapered tip did not detach but the innermost cylinder to which the taper tip was connected had detached from the delivery system.It turned out when the top stent was deployed and the delivery system was attempted to be removed.There was no damage to the delivery system or packaging prior to unboxing.Following this, the endurant stent graft limbs (etlw1620c124ej <(>&<)> etlw1624c124ej) were implanted in both cias as planned, and the procedure was completed.It was reported that during the index procedure, the patient was temporarily in hemorrhagic shock due to intraoperative bleeding.A type ia was identified several daysafter the index procedure.The physician suspects that a type iii or a type iv endoleak may be present.It is unknown whether the direct cause of bleeding and endoleak was caused by delivery system trouble or degradation.Per the physician the cause tip malfunction on the delivery system was undetermined, however the physician suspected an adhesion error between the back-end wheel and the tapered tip within the delivery system.There wasn't any vessel thrombus or calcification that may have caused the deployment problems, it was said there was almost no tortuosity in the aortic neck or external iliac artery.The access vessels were also not difficult in blood vessel diameters and shapes.No additional clinical sequelae were reported, and the patient will be monitored.

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.

Manufacturer Narrative

Additional information received: it was reported that the innermost chamber where the spindle, sleeve and taper tip are connected had detached.The bottom and the top of the spindle were not detached.It was clarified that the pull through necessary once the stent graft was deployed following the bailout technique refers to the connection from the peripheral outside the body to the central outside the body with a single wire, also known as tag of wire.The type ia and the suspected unknown endoleak ( possibly iv, iiia or iiib) were identified on follow up ct from 6 days after the index procedure.It was clarified that all 3 implanted devices are suspected to contain the unknown endoleak.The hemorrhage occurred before the limbs were implanted.It was clarified that the term degradation refers to the disassembling of the delivery system.Film evaluation summary: the reported deployment issue, difficulty to remove the delivery system, component detachment , hemorrhagic shock and endoleak could not be assessed from the pre-implant films provided, therefore, the cause of the events could not be determined.Procedural angiograms showing deployment of the main body bifurcate, removal of the device and component detachment were not available for assessment of the events.Post-implant ct¿s were not available for review so assessment of the stent graft in-vivo configuration and reported endoleaks could not be performed.It is possible that anatomical factors such as thrombus and calcification observed along the aortic neck could have contributed to the reported type reported type ia endoleak, but this could not be confirmed.Calcification was also noted along the aneurysm sac and iliac arteries and may have contributed to the reported additional endoleak and difficulty to remove the delivery system, but again, this could not be confirmed.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 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: 18675819
• MDR Text Key: 335010794
• Report Number: 9612164-2024-00701
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESBF2514C103EJ
• Device Catalogue Number: ESBF2514C103EJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2023
• 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