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

Model Number ETBF3216C145EE

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/03/2023

Event Type  Injury  

Event Description

An endurant ii bifurcate stent graft was implanted in the endovascular treatment of a 92mm aaa.The patient also had a common iliac aneurysm and dissection of the main descending thoracic segment. the neck of the aneurysm was short and twisted at an angle of 90°.  it was reported that during the index procedure, the main body bifurcate was delivered and deployed as normal , but during the removal of the delivery system, the tapered tip of the delivered system abutted against the upper corner of the aneurysm neck blood vessel wall and the bare stent section of the main body stent was stuck, making it difficult to withdraw the delivery system.  the tapered tip and spindle above it broke and could not be removed.The rest of the delivery system was removed successfully.  it was said as the broken tip of the delivery system was at the corner of the aneurysm neck, it could not be removed through interventional means.The risk of taking it out via an open procedure was compared to the risk of leaving the tip in and it was decided to not perform an open abdominal surgery and place the patient under observation.  per the physician the cause of the event was anatomy and the  neck of the aneurysm was twisted and short, which made it very difficult for the stent delivery system to go up and down.No additional clinical sequalae were provided and the patient will be monitored.

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.

Manufacturer Narrative

Product analysis conclusions: the delivery system returned with the external slider and backend wheel in the home position.The taper tip, spindle and a section of the spiral member had detached 13.9cm from the stent stop.Deformation was visible to the spiral and sleeve at the detachment site.Separation of spirals and a bend were observed proximal to the detachment site.Deformation was visible along the graft cover over the spiral.The reported detachment was confirmed through analysis.The reported difficulty to remove was likely confirmed and the tip detachment was confirmed on the films provided.The cause of the events was most likely to have been related to the extreme off label angulation observed in the infra-renal aortic neck.Although angiogram videos showing attempts to remove of the delivery system, and the exact moment of tip detachment were not seen , the anatomical factors such as tortuous and severely angulated neck, reported to have been the cause of the events were observed on the still images returned.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 BIFURCATED 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: 17096391
• MDR Text Key: 316860793
• Report Number: 9612164-2023-02472
• 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: 06/23/2023

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 Model Number: ETBF3216C145EE
• Device Catalogue Number: ETBF3216C145EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2022
• 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
• Patient Outcome(s): Other