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

Model Number ESBF2814C103EJ

Device Problems Difficult to Insert (1316); Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/01/2024

Event Type  Injury  

Event Description

An endurant iis stent graft (esbf2814c103ej) was implanted during the endovascular treatment of a 50mm abdominal aortic aneurysm.It was reported during the index procedure, the contralateral short rim origin was occluded (kinked) during the implantation of the endurant iis main body stent graft, preventing cannulation.As a result, the contralateral side leg was left unfinished.The kink interrupted blood flow in the contralateral leg of the bifurcate.To prevent influx into the aneurysm, intervention was performed, and an endurant ii extension (etcf2828c49ej) cuff was added from the main body region to the main ipsilateral leg.Additionally, the contralateral side common iliac artery (cia) was coiled, and ff bypassed.A type iv endoleak was identified and the procedure was completed.The type iv endoleak did not appear to be jetting, nor was the physician dissatisfied.There as no significant increase in procedure time or intervention as a result of the type iv endoleak.Per the physician the cause the deformation/ occlusion was due to user error, the contralateral side short rim origin was positioned in the small fold of the bent neck in error.No additional clinical sequalae were provided and the patient will be monitored.

Manufacturer Narrative

Product analysis conclusion: the reported occlusion of the contralateral gate of the main body graft during implantation and type iv endoleak could not be confirmed on the pre-implant images provided; therefore , the cause of the events could not be determined.It is possible that anatomical factors including the long and tortuous infrarenal aortic neck may have contributed to the reported deployment of the contralateral leg of the bifurcate in a small fold of the angulated neck , but this could not be confirmed.The patient's tortuous anatomy coupled with heparin dose, outflow resistance, imaging quality, and volume of the aneurysm sac may have also contributed to the reported type iv endoleak , but this could also not be confirmed.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

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 IIS BIFURCATED 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: 18939042
• MDR Text Key: 338067191
• Report Number: 9612164-2024-01329
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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: ESBF2814C103EJ
• Device Catalogue Number: ESBF2814C103EJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2023
• 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: 78 YR
• Patient Sex: Female