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

Model Number ETCF2828C49E

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2024

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 iis stent graft system was implanted during the endovascular treatment of a 50mm abdominal aortic aneurysm.It was reported during the index procedure, the endurant cuff (b)(6) deployed unevenly.It was observed that the left side of the graft landing higher than the right.Per the physician the cause was due to abnormal device deployment.No additional clinical sequelae were reported, and the patient is fine.

Manufacturer Narrative

Additional information received; it was reported that deployment steps where followed per the ifu.There was posterior/anterior angulation noted.It was clarified that the endurant bifurcated device was landed low intentionally due to anatomy, therefore the cuff was implanted.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.

Manufacturer Narrative

Film evaluation summary: the reported deployment issue- left side of the endurant cuff stent graft landing higher than the right could not be fully confirmed from the single still angiogram film provided; therefore, the cause of the event could not be determined.Lack of pre-implant cts did not allow for evaluation of the pre-implant anatomy and procedural angiograms showing the deployment of the stents were not provided for a thorough assessment of the event.It is possible that the reported patient's angulated neck may have contributed to the reported event, but this could not be confirmed on this review.B5: additional information received: it was confirmed that the stent graft etcf2828c49e (b)(6) appeared normally contained within the graft cover of the delivery system prior to use and a second cuff etcf2828c49e (b)(6) was implanted to address the reported deployment issue with the device etcf2828c49e (b)(6).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 AORTIC 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: 19103811
• MDR Text Key: 340107284
• Report Number: 9612164-2024-01789
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00613994991447
• UDI-Public: 00613994991447
• 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,Followup,Followup
• Report Date: 05/07/2024

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 Expiration Date: 05/29/2024
• Device Model Number: ETCF2828C49E
• Device Catalogue Number: ETCF2828C49E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/15/2024; 04/25/2024
• Supplement Dates FDA Received: 04/15/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male