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); Malposition of Device (2616)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/08/2024

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 60mm abdominal aortic aneurysm.The diameter at the proximal neck was 25mm <(>&<)> 26mm distally with a neck length of 12mm.The neck was conical with severe neck thrombus measuring 3-4mm.Moderate vessel calcification was observed in the right iliac, with mild vessel calcification to the left iliac.It was reported during the index procedure, before esbf3614c103e was inserted, while gaining access on the left side due to the tortuosity and the aneurysmal sac, getting the wire up the left lower extremity took multiple attempts.Before deployment of the bifurcate, the proximal markers were observed above the renal arteries and the graft deployment commenced.After 3 stents were deployed the physician adjusted for parallax.Angio was again taken and the physician lined up the proximal markers at the marker of the left renal and the device was deployed with no issues noted.Final angiogram revealed occlusion of the patient's left renal artery.The proximal marker of the esbf3614c103e appeared to be occluding the left renal.The left accessory renal was patent.The physician attempted to cannulate the left renal from the groin using a 7f tourguide, and a non mdt catheter but was unsuccessful.After multiple attempts with 035 and 014 wires, the physician decided to close the groin.Per the physician the cause of the renal coverage is undetermined.No additional clinical sequelae were reported, and the patient will be monitored.

Manufacturer Narrative

Correction to ed: a type ii endoleak was noted at the end of the procedure.Additional information received : it was reported the cause of the renal coverage was a very angulated aortic neck.The accessory renal artery was also noted.The patient is doing fine with ok creatinine levels reportedly.Product analysis conclusion: the reported renal artery occlusion and inaccurate delivery could not fully confirmed on the limited films received, therefore a cause could not be fully determined.The reported type ii endoleak could not be assessed.The availability of angiograms or full post-operative ct¿s could have allowed for a thorough analysis of the stent grafts in vivo configuration and the reported events, but these were not provided for review.It is likely that the patient's anatomy and the angulated aortic neck, which could be appreciated on the pre-implant films received, did contribute to the reported events, but this could not be fully confirmed.Analysis of the returned still images did not reveal any obvious out of specification stent graft integrity issues.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: 19095221
• MDR Text Key: 339989738
• Report Number: 9612164-2024-01767
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: ESBF3614C103E
• Device Catalogue Number: ESBF3614C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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): Other
• Patient Age: 77 YR
• Patient Sex: Male