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

Model Number ETLW1620C82E

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: three (3) images were received from the account.The images capture the shelf carton label and identify the customer facing number (cfn) as etlw1620c82e, serial number (b)(6).The side label is partially lifting.The shelf carton tab appears to be damaged.Slight crease visible to the shelf carton and label.The reported device marking issue was not confirmed based on the image review.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

It was reported when etlw1624146 (b)(6) box was opened during a procedure, the sealed limb contained inside was etlw1620c82e - serial # (b)(6).The device contained within the box with serial # (b)(6).It was reported that none of the devices were used.

Manufacturer Narrative

Product analysis: the endurant limb graft shelf carton label identified device as etlw1620c82e (b)(6).The shelf carton end tabs were intact with no evidence the tabs had been removed.The product pouch was removed from the shelf carton.The pouch label identified the device as the device as etlw1624c146e (b)(6).The device handle label was scanned and confirmed as (b)(6).The reported device marking issue 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 ILIAC 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: 18109807
• MDR Text Key: 328489448
• Report Number: 9612164-2023-05146
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169467521
• UDI-Public: 00643169467521
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

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: ETLW1620C82E
• Device Catalogue Number: ETLW1620C82E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2022
• 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