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

Model Number ESBF2314C103E

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2024

Event Type  malfunction  

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 penetrating aortic ulcer (pau) of the infra-renal aorta.The proximal aortic neck diameter measured 19mm proximally <(>&<)> 19mm distally with a neck length of 40mm.Infrarenal angulation was 28 degrees.Mild neck calcification was present.Mild bilateral iliac calcification was noted.The celiacwas enlarged at 16.8mm and the distal lcfa also enlarged at 15.7mm due to the fact treating a pau minimal oversizing in cia's sealing with 13mm limbs was recommended.It was reported at the one-month follow-up on 23-apr-2024, ct imaging identified mild infolding just above the flow divider of esbf2314c103e.No endoleaks were detected, and the pau showed no signs of expansion/ filling.Per the physician the cause the infolding is undetermined.No additional clinical sequelae were reported, and the patient will be monitored.

• Brand Name: ENDURANT IIS BIFURCATED 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: 19174220
• MDR Text Key: 340945147
• Report Number: 9612164-2024-01975
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439993
• UDI-Public: 00643169439993
• 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: 04/24/2024

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
• Device Operator: Health Professional
• Device Model Number: ESBF2314C103E
• Device Catalogue Number: ESBF2314C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2024
• Initial Date FDA Received: 04/24/2024
• Date Device Manufactured: 09/19/2023
• 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 Age: 81 YR
• Patient Sex: Male