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

Model Number ETLW1616C124EE

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problems Pain (1994); Shock (2072); Rupture (2208)

Event Date 09/24/2023

Event Type  Death  

Event Description

An endurant ii stent graft was implanted during the endovascular treatment of an 66mm abdominal aortic aneurysm.It was reported on the same day, following the index procedure, the patient experienced severe abdominal pain.Ct imaging revealed significant contrast agent leakage within the aneurysm, which was suspected to be caused by a postoperative endoleak.Emergency surgery was performed to identify the source of the endoleak.During the surgery, segmental angiography was carried out on both the left and right limbs.Comparing the contrast imaging on the right side, it was observed that the contrast agent at etlw1616c124ee ((b)(6)) in the left limb had severely overflowed, this was thought to be a type iii endoleak , that the stent graft material had cracked.The physician suspected damage to the stent, and an additional limb of the same model, etlw1616c124ee, was implanted on the left side which resolved the endoleak.While another stent graft with the same specifications was implanted on the right side also, it was thought there may have been any endoleak on this side also but was not obvious.Embolization was then performed using bioprotein glue.The endoleak was confirmed as resolved post the implant of both limbs.The following day, on the (b)(6) 2023, the patient's blood pressure dropped, the patient went into shock and an aneurysm rupture was diagnosed.The patient was transferred to icu but despite rescue attempts the patient expired.It was said a continuous endoleak led to the aneurysm rupture, which led to the patients death.Per the physician the cause of the endoleak and subsequent death was attributed to damage to the stent graft.There was no complaint against the endurant bifurcate that led to the endoleak, rupture and death.No additional clinical sequalae were provided and the patient expired.

Manufacturer Narrative

Concomitant medical products: section d information references the main component of the system.Other relevant device(s) are: product id: e tlw1613c124ee, serial/lot #: (b)(6), ubd: 04-apr-2025, udi#: (b)(4).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

Film evaluation summary: the reported endoleak was confirmed on the films provided; however, the endoleak subtype and cause of the event could not be determined.The aneurysm rupture leading to the patient's death could not be confirmed.Lack of pre-implant ct's did not allow for a thorough assessment of the pre-implant anatomy and complete post-implant cts were not provided, therefore, a more thorough assessment of the stent graft in vivo configuration could not be performed.Endoleak interrogation via selective angiograms (i.E.Injecting contrast through several levels within the stent graft) was not seen, thereby making determination of the endoleak difficult.While a type iiib endoleak is unlikely to occur at index, anatomical factors that could lead to an acute fabric tear, such as vessel calcification was present and this endoleak type cannot be ruled out.Equally, this could have been a type iv endoleak due to increased graft porosity.Factors such as heparin dose, outflow resistance, imaging quality, and volume of the aneurysm have the potential to contribute to type iv endoleaks.It was not possible to assess the marginal sealing in the proximal and distal seal zones in the images provided.It is possible that a concomitant type ii endoleak due to patent collateral vessels feeding the aneurysm sac may have been present.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 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: 17948156
• MDR Text Key: 325794322
• Report Number: 9612164-2023-04695
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

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: ETLW1616C124EE
• Device Catalogue Number: ETLW1616C124EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/18/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2023
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Male