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

Model Number ETBF2816C166EE

Device Problems Leak/Splash (1354); Device Markings/Labelling Problem (2911)

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

Event Date 02/14/2023

Event Type  malfunction  

Event Description

An endurant ii bifurcate stent graft was implanted in the endovascular treatment of a 76mm ruptured aaa. it was reported that during the index procedure, the femoral access was established using an  18f sheath, the etbf2816c166ee stent graft was prepared to be delivered.It was found that the stent could not pass through at first, the physician  chose to withdraw the stent but it then passed through successfully after replacing the sheath with a 20f sheath.  after the stent graft was implanted in the patient's body, the patient's postoperative imaging showed a type i endoleak.Due to a aortic  neck problem, no other treatment was performed during the operation.  it was also reported that product packaging information was wrong, which made it impossible to distinguish whether the model was the first generation or the second generation endurant , and whether there were other problems.  according to the actual usage, the outer diameter of the delivery system could be determined as 20f, which did not match the stent of the second generation 18f.The outer packaging marks the delivery system as 18f, while the inner packaging marks it as 20f.It was confirmed the pouches of the endurant was sealed and intact prior to opening.It was said that, however, due to the incorrect packaging information, it was not clear whether the internal leakage was caused by the stent body.It is impossible to confirm whether the two are related, because the product condition of the stent itself cannot be determined through the information on the outer packaging, and whether there is a misjudgment of the surgeon during the selection of the stent and the use of it.The patient's aortic neck is also twisted and short and there may be many factors affecting the endoleak.Per the physician the cause of the endoleak is anatomy and a tortuosity of aortic neck and short anchoring area.No additional  clinical sequalae were provided will be monitored.

Manufacturer Narrative

Product analysis conclusion; a series of seven (7) photos were received from the account.The images confirm the information stated on the shelf carton label and the pouch labels do not align.The reported device marking issue was confirmed through the image review.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

Section h.2 film evaluation summary: the reported endoleak was confirmed on the films provided.Lack of pre-implant ct¿s did not allow for a thorough assessment of the p re-implant anatomy.Endoleak interrogation via selective angiograms (injecting from different levels within the stent graft) to help determine the source and rule out other potential endoleak sources was not seen, and only a single imaging view point (a-p) was observed in the films provided; thereby, making determination of the endoleak difficult.The noted anatomical consideration that are a likely factor in the occurrence of the endoleak could be appreciated (short and angulated aortic neck).It is most likely that the observed endoleak is a type ia endoleak which occurred due to the challenging aortic neck anatomy.However, other additional endoleaks such as a type iv or type ii from collateral vessels could not be ruled out.Analysis of the returned images did not reveal any out of specification stent graft integrity issues.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: 16552727
• MDR Text Key: 311579814
• Report Number: 9612164-2023-01153
• 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: 04/04/2023

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 Expiration Date: 05/05/2023
• Device Model Number: ETBF2816C166EE
• Device Catalogue Number: ETBF2816C166EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2021
• 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