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); Material Deformation (2976)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/17/2024

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 48mm rapid expanding abdominal aortic aneurysm.The diameter of the aorta at the proximal renal artery was noted as 29mm and 28 distal with a neck length of 20mm.The ima was coiled during the procedure.It was reported during the index procedure, multiple images of the renal arteries were taken and esbf3614c103e was landed precisely below the left accessory renal artery.Right after deployment, it was noted that the gate was not fully open and appeared to be kinked.Multiple attempts to canulate the gate with non-mdt catheters and a tourguide failed.The physician decided to complete the deployment and snare the wire.The device was removed and a long 16fr sheath was placed in the ipsilateral limb.Using a tourguide and 16fr sheath the wire was snared and pulled out from the left groin.The wires on the right and left were exchanged for non-mdt stiff wire.A reliant balloon was used to balloon at the gate to make 100% sure the position was at the gate.Left side deployment of etlw1613c156e was completed first as it was the gate side and the right side extended with etlw1613c146e.A reliant balloon was placed up the right side.Immediately upon ballooning the graft, the proximal graft markers were seen to move.3 markers moved to the patients right side.A second balloon was placed up simultaneously to balloon the main body.Both balloons were ballooned to make sure the supra renal stents were not stuck together and it was confirmed they were not.Ballooning was started at the bottom and worked up the graft as well as worked from top down to try to iron out the graft.Final run saw a proximal type ia endoleak.Ballooning was completed again with ivus.Esbf3614c103e was seen under ivus folded right down the center of the graft looking like two barrels.After ballooning another angiogram was taken to see if had resolved.The angiogram once again showed a big type i endoleak.After discussing options an aortic cuff (etcf3636c49) was placed successfully from the left with the left accessory renal artery sacrificed.A reliant balloon was used to mold the cuff out.Ivus was put back up and the graft was visualized to be fully opposed to the wall with no folding.One last final angiogram was preformed which showed the type ia endoleak was resolved.The patient was alert and awake on transfer to icu post op, per the physician the cause of the type ia endoleak and infolding is undetermined.No additional clinical sequelae were reported, and the patient is fine.

Manufacturer Narrative

It was confirmed that no vessel calcium or vessel thrombus that would have caused this issue.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: 19134877
• MDR Text Key: 340505254
• Report Number: 9612164-2024-01876
• 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
• Report Date: 04/19/2024

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: ESBF3614C103E
• Device Catalogue Number: ESBF3614C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Date Device Manufactured: 02/07/2024
• 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: 75 YR
• Patient Sex: Male