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

Model Number ESBF3614C103E

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Pain (1994); Rupture (2208)

Event Date 04/07/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e tlw1610c156e, serial/lot #: (b)(6), ubd: 01-nov-2018, udi#: (b)(4) ; product id: etlw1620c156e, serial/lot #: (b)(6), ubd: 08-sep-2018, udi#: (b)(4) ; product id: etlw1616c82e, serial/lot #: (b)(6), ubd: 05-dec-2018, udi#: (b)(4) 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 >55mm abdominal aortic aneurysm.It was reported approximately 7 years post the index procedure, the patient presented emergently experiencing back and abdominal pain.A ruptured aneurysm and limb separation (type iiia endoleak) was diagnosed. intervention was performed where an additional etlw1616c156e was placed to bridge the separation and treatment was complete.Per the physician the cause of the type iiia endoleak and rupture is undetermined.No additional clinical sequelae were reported, and the patient is fine.

Manufacturer Narrative

Additional information received: it was confirmed the type iiia endoleak occurred between the 36x14x103 main body to 16x10x156 limb.It was said that no calcification/tortuosity/ thrombus may have contributed to the endoleak.The rupture was caused by the type iiia endoleak , per the physician.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

Additional information received: it was reported that this limb was implanted on the contralateral leg during the index procedure etlw1620c156e.The other devices were implanted in the ipsilateral leg, likely in the following order: 16x16x82 followed by the 16x10x156 limb.It was confirmed that the etlw1616c156e was implanted in the contralateral side during the intervention.Film evaluation summary: the reported type iiia separation endoleak was confirmed on the films provided; however, the cause of the event could not be determined.Lack of pre-implant cts did not allow for assessment of the pre-implant anatomy and earlier post-implant cts were not provided for comparison of the stent graft in vivo configuration overtime.The position of the implanted devices appeared to differ from the reported one.Based on the images, the images provided, it appeared that 2 limb stent grafts were implanted along the contralateral leg ( likely etlw1616c82e , followed by etlw1610c156e distally) before the intervention while one limb stent graft (likely etlw1620c156e) was implanted in the ipsilateral side.The bifurcate dd not appear to be involved in the separation, as it was observed only between the two limb stent grafts implanted in the contralateral side.The junction between the most proximal contralateral limb stent graft and the contralateral gate of the main body bifurcate seems adequate.The aneurysm rupture could not be confirmed on the images, but it is possible that the type iiia endoleak was a contributing factor.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.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: 19114317
• MDR Text Key: 340224316
• Report Number: 9612164-2024-01817
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439955
• UDI-Public: 00643169439955
• 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: 05/15/2024

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: 07/12/2019
• Device Model Number: ESBF3614C103E
• Device Catalogue Number: ESBF3614C103E
• 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: 04/07/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/16/2024; 04/22/2024
• Supplement Dates FDA Received: 04/17/2024; 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2017
• 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: 82 YR
• Patient Sex: Male