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

Model Number ETLW1616C124E

Device Problem Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2024

Event Type  Injury  

Event Description

An endurant iis stent graft system was implanted during the endovascular treatment of a 52mm aaa.It was reported that 12 hours post the index procedure it was noted that the right limb etlw1610c156e was occluded due to being crushed in the distal aorta by the left limb etlw1616c124e.Intervention was performed where a thrombectomy was performed.A non-mdt stent was placed in the right limb at the proximal end.A 10x59 balloon expandable stent was paced at the same time in the left limb to prevent that side from being crushed, but the left limb was not blocked.Per the physician the cause of the event was anatomy related.It was noted that there was calcium present in the distal aorta.No additional sequelae were reported and the patients is fine.

Manufacturer Narrative

Film evaluation summary: the reported occlusive event was confirmed on the films provided.Although pre-implant ct's , which could have allowed for assessment of the pre-implant anatomy, were not available for review, it is likely that reported anatomical factors such as the reported calcified distal aorta and the relatively narrow distal aorta with a diameter of 19mm contributed to the observed compression and occlusion of the stent graft limb.Analysis of the returned films did not reveal any obvious 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 II ILIAC 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: 18854656
• MDR Text Key: 337072562
• Report Number: 9612164-2024-01128
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169467675
• UDI-Public: 00643169467675
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ETLW1616C124E
• Device Catalogue Number: ETLW1616C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2023
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 111 KG