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

Model Number ETBF2316C166EJ

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii bifurcate stent graft was implanted in the endovascular treatment of a 90mm abdominal aortic aneurysm.It was reported that during the index procedure, once the stent graft was deployed, the physician experienced difficulty removing the delivery system as the spindle and top stent were caught.Attempts were made to free the delivery system by using torque, balloon expansion, wire replacement and a pull through technique but these did not work.When the delivery system was pulled, the metal tapered tip separated from the delivery system.The abdomen was then opened, the main body part of the endurant was anastomosed with an artificial blood vessel to replace the artificial blood vessel.Non.Medtronic stents were implanted from the common iliac artery to the external iliac artery.It was noted that a part of the tip and metal shaft of the delivery system remained in the patients body.The endurant was partially explanted.As per the physician the cause of the event was anatomy.The case was one of ultra high flexion and this contributed to get the delivery system getting caught when trying to remove it.No additional clinical sequelae were provided and the patient is fine.

Manufacturer Narrative

Additional information received: it was reported there was damage noted on the external iliac artery which was due to stenosis.It was reported attempts were made to remove the tapered tip from the patient but it was in a deep position of the aorta and it could not be removed product analysis the reported detachment and difficult to remove events could not be assessed on the films provided; however, the reported anatomical factors that are likely to have contributed to the events could be appreciated on the still ct images.Procedural angiogram showing attempts to remove the device were not received for a thorough analysis of the event.It is likely that the severely angulated aortic neck was a factor in the difficulty in removing the device and subsequent detachment of the tapered tip.It is also possible that the narrowed and calcified iliac vessels may have made removal of the device more difficult.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 have not 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 BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11884191
• MDR Text Key: 252701011
• Report Number: 9612164-2021-02064
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

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 Expiration Date: 12/08/2022
• Device Model Number: ETBF2316C166EJ
• Device Catalogue Number: ETBF2316C166EJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 93 YR
• Patient Weight: 64