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

Model Number ESBF3214C103EE

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e tlw1613c93ee, serial/lot #: (b)(6), ubd: 02-may-2024, udi#: (b)(4).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 iis (esbf3214c103ee / (b)(6)) was intended to be implanted during the endovascular treatment of an abdominal aortic a neurysm.It was reported during the index procedure, the physician unboxed the stent graft labelled esbf3214c103ee; (b)(6) and inserted the device into the patient.Upon release of the graft, the physician discovered that the implanted device was not the intended esbf3214c103ee but an endurant limb (etlw1613c93ee / (b)(6)).A non-mdt balloon was used to reposition the endurant limb within the aneurysm.The physician then implanted an additional endurant iis graft (esbf3214c103ee / (b)(6)) along with additional endurant limbs (etlw1616c124ee / (b)(6)) and (etlw1620c124ee / (b)(6)).The procedure was successfully completed with no complication to the patient.Per the physician the cause of the incorrectly implanted device was due to a medtronic error and confirmed during the procedure that the (esbf3214c103ee / (b)(6)) box and pouch was sealed but the label of the pouch did not match the box.However, a check was performed on the two serial numbers; esbf3214c103ee; (b)(6) & etlw1613c93ee; (b)(6) which confirmed that esbf3214c103ee; (b)(6) was recorded as implanted correctly during a previous procedure by a different physician on 26-sep-2023.The endurant limb etlw1613c93ee; (b)(6) was not found at a cycle count and based on this, it is possible that during the procedure on (b)(6) 2023, etlw1613c93ee ((b)(6)) was opened but not used and incorrectly put back into the empty box of the implanted esbf3214c103ee ((b)(6)).No additional clinical sequelae were provided, and the patient is fine.

• 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: 18581136
• MDR Text Key: 334763229
• Report Number: 9612164-2024-00428
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESBF3214C103EE
• Device Catalogue Number: ESBF3214C103EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 01/25/2024
• Date Device Manufactured: 06/16/2023
• 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
• Treatment: "SEE H10...."
• Patient Sex: Male