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

Model Number ETLW1613C124EE

Device Problem Defective Component (2292)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

An endurant  ii limb (etlw1613c124ee) was intended to be implanted during the endovascular treatment of an abdominal aortic aneurysm.It was reported that during the index procedure when attempting to insert the limb delivery system it could not be inserted into the vessel without using higher resistance which may have risked causing a vascular lesion.It was noted the reason for this was an unusual configuration at the end of the delivery system near the tip where incomplete closure of the sheath over the limb was observed.Another endurant limb was used to complete the procedure.No cause was provided.No additional sequelae were reported and the patients is fine.

Manufacturer Narrative

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.

Manufacturer Narrative

It was reported, that the gap between the graft cover and tapered tip was not identified, prior to introduction into the patient.It was said, the delivery system was not examined in detail.But, from a cursory inspection.The delivery system appeared normal.In reference to whether any vessel tortuosity, calcification or angulation have caused the gap, during attempts to insert into the vasculature.It was said, the patient was slim, the puncture distance to the vessel wall was not far and was prepared by using a clamp to spread the soft tissue up to the vessel wall.A non mdt percutaneous suture system was inserted into ssl at 12 o'clock.For this purpose, the puncture site of the vessel wall was pre-dilated with an 8f stylet.This was done, without any problems.Any kinking or angulation when inserting the delivery system over a stiff was ruled out.It was said, it was possible, that a calcium deposit in the wall of the vessel may have caused a gap to form.This would not have been noticed at first, when inserting the endurant ii leg into the vessel.After the complaint, limb in question could not be advanced.Another prosthetic limb was able to be advanced without any problems.It was confirmed, that the physician used normal force and only pushed with more force when the tapered tip had already been inserted into the vessel lumen.And there was resistance to push i.E, after the gap in the delivery system got caught in the vessel wall.It is assumed, the gap was present from the start, during normal advancement.The graft cover got caught in the vessel wall and hindered further advancement.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.

Manufacturer Narrative

Device evaluation summary: the device returned with the external slider in the home position.The graft cover tip material was deformed and raised with a partial radial tear observed.A gap of 0.4mm was observed between the graft cover tip and the taper tip (pass); specification is 0.5mm max.The gap was larger where the graft cover tip material was deformed and raised.A kink was visible on the graft cover over the graft.The reported dimensional deviation was confirmed through analysis along with deformation in-vivo.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 II ILIAC 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: 17994685
• MDR Text Key: 326365091
• Report Number: 9612164-2023-04818
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 01/15/2024

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: ETLW1613C124EE
• Device Catalogue Number: ETLW1613C124EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 11/02/2023; 12/21/2023
• Supplement Dates FDA Received: 11/08/2023; 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• 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