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

Model Number ETBF2513C166EE

Device Problems Material Integrity Problem (2978); Positioning Problem (3009)

Patient Problems Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 08/02/2023

Event Type  Injury  

Event Description

An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of a 60mm aaa.  it was reported that during the procedure, the surgeon established the patient  access, confirmed the model, and confirmed that the packaging was intact without damage and compression before unpacking.  the stent was disassembled for routine insertion, and the hydrophilic coating was soaked with wet gauze.There was no smooth feeling during the soaking process.The operator suspected that there was no hydrophilic coating on the outside of the stent, and tried to replace the stent, but there was only one of this model, so the surgeon could only continue to use it to make the operation go smoothly.When the stent entered the patient's body, the operator felt huge resistance and the patient felt unbearable pain.After many attempts, the patient suffered from spasms due to the pain and locked the stent.After waiting for a long time for the patient's convulsion to disappear, the stent was withdrawn from the body.The stent could then be delivered to the target position with a non mdt hydrophilic coated introducer sheath.The operator reported that the stent and the dsf sheath were still difficult to pass through.The operation time was extended by 2 hours and 25 minutes due to the lack of hydrophilic coating. no vessel or access damage was reported due to the repeated attempts to deliver the graft.Per the physician the cause of positioning difficulties was due to the stent not having a hydrophilic coating.  no additional clinical sequalae were provided and the patient 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

Product analysis conclusion :prior to decontamination a tactile test confirmed coating presence along the entire length of the graft cover.Device decontaminated with cidex-opa pending further device testing to support the final product analysis findings.The device returned with the external slider in the open position, opened approx.25mm and the graft cover retracted approx.25mm.No graft was loaded in the device.A kink was evident to the graft cover immediately under the strain relief.The reported positioning difficulties and coating issue could not be confirmed through analysis.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: 17601404
• MDR Text Key: 321711208
• Report Number: 9612164-2023-03816
• 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: 09/05/2023

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: ETBF2513C166EE
• Device Catalogue Number: ETBF2513C166EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2022
• 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
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 65 KG