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

Model Number ETLW1620C156EE

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 04/10/2024

Event Type  malfunction  

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 limb (etlw1620c156ee/ v31307970) was intended to be implanted during the endovascular treatment of an approx.55mm abdominal aortic aneurysm.It was reported during the index procedure, when trying to deploy etlw1620c156ee, the delivery system did not work.The delivery system was removed and replaced with another endurant stent graft limb (etlw1620c156ee / v31314000) of the same size.Per the physician the cause of the deployment failure was not determined.No additional clinical sequelae were provided, and the pat ient is fine.

Manufacturer Narrative

Additional information received: per the physician the graft was placed at the desired level and deployment was began in the usual way by rotating the back end wheel to release it.It went well in the beginning, until the ring came just below the upper markers (2-3 mm).After this, there was no movement even though the physician continued to turn.The physician aslo tried to push the gray switch back to pull down the outer sleeve and release the graft that way, but the switch was "stuck".It was felt that there was a tension in the system so that when it was left go it all slipped back a little.None of the stent deployed and the ifu was followed.The entire stent graft system was then removed.There was no damage noted to the delivery system prior to inserting into the patient.It was said the access vessels were twisted but there were no problems with moving the system up (and the next graft released without any problems).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 ILIAC 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: 19125380
• MDR Text Key: 341005853
• Report Number: 9612164-2024-01842
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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
• Report Date: 04/17/2024

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: ETLW1620C156EE
• Device Catalogue Number: ETLW1620C156EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/17/2024
• Date Device Manufactured: 12/05/2023
• 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 Sex: Male