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

Model Number UNK-CV-SR-ENDUR-II

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problems Rupture (2208); Insufficient Information (4580)

Event Date 04/16/2024

Event Type  Injury  

Manufacturer Narrative

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 Description

An endurant stent graft was implanted during the endovascular treatment of an abdominal aortic aneurysm.It was reported approximately 4 years post the index procedure, during an emergency medical consultation, ct imaging revealed that the rim of the stent graft implanted in the left common iliac artery (cia) had become loose from its original position, resulting in a type ib endoleak and rupture of the aneurysm, necessitating emergency surgery. cannulation was performed from the peripheral end of the dislodged rim, and endurant limb etlw1613c124ej was implanted in the upper internal/external branch.A non-mdt stent was added to extend from there to the external iliac artery (eia).Ct confirmed no endoleak and the intervention procedure was completed without any problems.Per the physician the cause of the type ib endoleak and rupture is undetermined.No additional clinical sequelae were reported, and the patient is fine.

Manufacturer Narrative

B5; additional information received : it was clarified that stent distal margin was placed at the level of the left internal and external iliac artery.The stent graft migrated to the middle of the left common iliac artery, resulting in the type ib endoleak.There was some vessel tortuosity observed, but it was stated that it was an emergency surgery and there was no ct data, so it was not possible to make an accurate evaluation.It was confirmed that the intra-operative contrast revealed a clear type ib and the physician inferred the type ib led to the aneurysm rupture.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.

• Brand Name: ENDURANT II 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: 19133495
• MDR Text Key: 340487107
• Report Number: 9612164-2024-01868
• 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: 04/29/2024

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: UNK-CV-SR-ENDUR-II
• Device Catalogue Number: UNK-CV-SR-ENDUR-II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/29/2024
• 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