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

Model Number ETUF2814C102EJ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 10/23/2023

Event Type  Injury  

Event Description

A patient present to hospital with an enlarged aneurysm.At a different hospital, 1 year before the patient presented with intermittent claudication and underwent computed tomography (ct), which revealed thoracic aortic aneurysm (taa), aaa-ciaa, and right external iliac artery aneurysm (eiaa) of 51.8 mm, 47.4 mm, 71.5/31.9 mm (right/left), and 26.3 mm in diameter, respectively, occluded below the renal artery (ra) to the bilateral eia.Surgery was not indicated for the aneurysms at that time.At one year follow-up, the taa, aaa, ciaa, and eiaa were enlarged with a diameter of 56.1, 48.4, 74.0/33.0 (right/left), and 26.3 mm, respectively.The taa, aaa-ciaa, and right eiaa were occluded extensively.There was no access for device insertion in the taa surgery; therefore, a two-stage surgery was planned.In the first stage, endovascular aortic repair (evar) with chimney stent grafting of the left ra was performed for the aaa-ciaa, and in the second act, thoracic evar (tevar) with two debranching procedures was planned for the taa.Under general anesthesia, treatment was performed through the left axillary, left femoral, and right internal and external iliac arteries using a retroperitoneal approach.The right eiaa was resected, and the right internal iliac artery was ligated.Using a 6-fr , 5-fr non mdt guidewires and 0.035-inch non mdt  guidewire from the left femoral artery, the occluded area under the ra was detected from the left eia.Attempts were made to penetrate the occlusion between the ras.Access through the hard fibrin cap was difficult.A similar procedure was performed for the left axilla and right ciaa, where penetration was again difficult.Access was achieved and the penetration site was confirmed by repeated angiography and fluoroscopy.  it was passed from the subintimal space near the left ra to the true lumen at the level between the left and right ras.The microwire was inserted into the descending aorta, and its location confirmed using intravascular ultrasound, while advancing in a pulsatile manner, passing between the bilateral ras in the true lumen.A balloon was used to dilate the occlusion.  a 6-fr non mdt catheter, non mdt support catheter, and non mdt guidewire were inserted into the left ra from the left axillary artery, and a non mdt stent with a dimension of 6 × 25 mm was inserted into the left ra along the thruway.An endurant ii aui etuf2814c102ej graft was placed between the left and right ra.The non mdt limb was placed up to the distal eia.The surgery was completed.The aortic and left renal artery stent was patent.  the patient was extubated in the operating room and returned to the hospital ward.Plain ct and abdominal ultrasonography confirmed no abnormalities, and the patient was discharged on the 14th postoperative day on the 51st postoperative day, two preplanned debranching tevar procedures were performed with non mdt stent grafts for taa, and the patient was discharged on the 16th postoperative day.  after 1 year and 6 months, the symptoms of intermittent claudication in the right lower extremity worsened, and a femoro-femoral crossover bypass was performed.The patient is alive 4 years after the first surgery.

Manufacturer Narrative

Medtronic received the following information from a literature article entitled; use of the outback re-entry device for occluded abdominal aortic aneurysms with bilateral common iliac artery aneurysms noriaki kuwada, yuji kanaoka, yasuhiro yunoki, atsushi tabuchi, yoshiko watanabe, taishi tamura, kohei furusawa, takahiko yamasawa, kazuo tanemoto, annals of vascular surgery - brief reports and innovations, volume 3, issue 4, 2023, https://doi.Org/10.1016/j.Avsurg.2023.100225.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

B5; additional information received: it was confirmed the intermittent claudication symptoms that occurred 18 months post the index procedure were not related to the endurant stent graft and were related to the patients own medical history.There was no blood flow to the peripheral blood vessels because the artery was occluded.It was confirmed there are no complaints against the endurant stent graft.It was originally implanted because there was a vascular occlusion and symptoms of lameness.Additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803 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 II AUI 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: 19190986
• MDR Text Key: 341158248
• Report Number: 9612164-2024-02008
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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: ETUF2814C102EJ
• Device Catalogue Number: ETUF2814C102EJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/22/2024
• 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