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

Model Number	ETLW1620C156E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis conclusion: one image capturing the endurant device handle was received.The screw gear components are broken at the end of the threads and at the end of the component.The reported deformation in-vitro was confirmed through image review.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
An endurant ii limb etlw1620c156e was intended to be implanted as part of the endovascular treatment of a 60mm aaa.It was reported that during the procedure, upon opening the devices packaging, it was noted that the back end handle was broken.The box itself was in perfect condition.The box and inner pouch were completely sealed prior to opening.A different stent graft was then used to continue with the procedure.  no cause was reported.  no additional clinical sequalae were provided and the patient was not involved.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: 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: 19519721
• Report Number: 9612164-2024-02789
• Device Sequence Number: 8251751
• Product Code: MIH
• UDI-Device Identifier: 00643169467545
• UDI-Public: 00643169467545
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P10021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2024
• Device Model Number: ETLW1620C156E
• Device Catalogue Number: ETLW1620C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown