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

Model Number ENCF3636C45EE

Device Problems Difficult to Insert (1316); Device Damaged by Another Device (2915)

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

Event Date 07/10/2023

Event Type  malfunction  

Manufacturer Narrative

Product analysis conclusion: the reported endoleak was confirmed on the films provided; however, the cause and subtype of endoleak could not be conclusively determined.Endoleak interrogation via selective angiograms ( i.E.Injecting contrast from different levels within the stent graft) to help determine the source and rule out other potential endoleak sources was not seen, thereby making determination of the endoleak difficult.While a type ia endoleak cannot be ruled out, as the presence of neck thrombus could have been a contributory factor, it appears most likely that an acute type iv endoleak near the flow divider due to the higher porosity in that portion of the stent graft was present.It is possible that this likely type iv endoleak may have been exacerbated by slight fabric stretching in the area.Other factors such as heparin dose, outflow resistance, imaging quality, and volume of the aneurysm sac may have also contributed to this endoleak.The reported difficulty to insert could not be confirmed.Procedural angiograms showing attempts to insert the endurant cuff was not received for a thorough assessment of the event.It is possible that that patient anatomical factors, such as vessel tortuosity along with the narrow diameter of the distal stent graft margin of the right limb stent graft, where the endurant cuff was attempted to be inserted , may have been contributory factors to this event.Analysis of the returned films did not reveal any stent graft integrity issues.Product analysis #(b)(4): a series of four (4) images were received from the account including an image of five (5) endurant delivery systems.The complaint devices are not identified on the image.An image of the device handle label and shelf carton labels were received.The labels confirm the customer facing number (cfn) and serial number as reported in gch.The type ia endoleak and insertion difficulties could not be confirmed based on the images received.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii stent graft system was implanted during the endovascular treatment of a 51mm abdominal aortic aneurysm.Embolization of left internal iliac artery was also completed.It was reported during the index procedure the main body (36x16x145mm) was positioned at the opened of the lower edge of the left renal artery and deployed.A 16x16x124mm) limb was inserted into the main body of the left iliac leg and deployed.A (16x10x124mm) endurant iliac branch stent was inserted into the right iliac leg, the stent covered the internal iliac artery with the tail end was located in the middle and upper part of the external iliac artery.Postoperative angiography showed the proximal end of the aneurysm had a obvious endoleak, and the part above the bifurcation of the stent had membrane leakage.The physician elected to implant an endurant  (36x45mm) cuff to remedy.When implanting the cuff the physician first tried to pre-dilate with a 16f sheath.The sheath was removed and the cuff was pushed, however the stent became stuck in the distal iliac leg with a diameter of 10 and couldn't pass through.A 20f sheath was then used to open the access step by step, but the sheath also became stuck at the distal end of the original stent and could not pass through.The stent was unable to pass and could not be implanted.It was said when the sheath was put on, the 20f sheath couldn't be pushed, and it has been standing against the distal end of the original 1610124 iliac leg, so there was no way to put the stent through the sheath.The approach was twisted and thin, and it was even more difficult to directly rely on the stent on the hydrophilic coating, so its used was abandoned.It was confirmed the endurant limb was implanted in the intended position and there was no obvious reason why the limb interfered with the attempted implant of the endurant cuff: the distal end of the iliac leg was too thin (10 distal) and the vessels themselves were in poor condition  a (10x80mm) non mdt balloon was used to dilate the right external iliac artery.The sheath was replaced with a 18fr hydrophilic coated delivery sheath and the physician inserted a 36x45mm non mdt aortic extension along the guide wire.The proximal end was positioned under the superior mesenteric artery, the distal end overlapped with the upper part of the stent by about 20mm.After confirming the position by angiography again, the stent was deployed according to the steps, and it was introduced in the balloon dilation overlapping area. a type i endoleak of abdominal aortic aneurysm was basically resolved.A small amount of delayed membrane leak was seen, the position and shape of each stent were good.The blood flow of both common iliac arteries and external iliac arteries was smooth, and bilateral internal iliac arteries did not develop.All guide wire catheters were removed, and the bilateral femoral arteries were closed with pre-embedded vascular occluder and the procedure completed. per the physician the cause of the type i endoleak and insertion difficulties are undetermined.No additional clinical sequelae were reported and the patient will monitored.

Manufacturer Narrative

Product analysis conclusion: the device returned with the external slider in the home position and the backend wheel partially open.A gap of 3.5mm (fail); specification is 1.0mm was observed between the graft cover tip and the taper tip.Slight deformation was visible to the graft cover tip material.The taper tip was curved.There was no further deformation observed to the device.The reported insertion difficulties were confirmed through analysis.Ruler cal # 7367.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT EXTENSION CUFF 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: 17449425
• MDR Text Key: 321335364
• Report Number: 9612164-2023-03525
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

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: ENCF3636C45EE
• Device Catalogue Number: ENCF3636C45EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/11/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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: 75 YR
• Patient Sex: Male