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

Model Number	ETBF2816C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e tlw1616c146e, serial/lot #: (b)(6), ubd: 12-dec-2024, udi#: (b)(4); product id: etlw1616c93e, serial/lot #: (b)(6), ubd: 12-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.
Event or Problem Description
An endurant ii stent graft system was implanted during the endovascular treatment of a ruptured 53mm abdominal aortic aneurysm.It was reported at the end of the index procedure, the physician believed a type ii endoleak was seen.The patient received a ct and was still experiencing symptoms.It was believed the patient had a type iii endoleak near the bifurcation of the device.The physician took the patient back to the or for an angiogram and possible repair.Angio demonstrated an endoleak which was believed to be from the ima.The endoleak could not be accessed from the ima so the physician decided to perform an open repair and ligate the ima.After ligation the aneurysm sac was still pulsatile.A balloon was placed in the graft at the level of the renal arteries and inflated.The pulsatility in the aneurysm stopped.This confirmed either a type ia or a type iii endoleak.The physician next placed a proximal cuff and 2 x23mm non mdt limbs to raise the graft bifurcation.This did not resolve the pulsation in the aneurysm sac.At this point it was decided to partially explant the bifurcated device.When the physician opened the aneurysm the only endoleak he could see was from the lumbar arteries, but did not believe those could caused the of the pulsation in the aneurysm.The suprarenal stent and roughly 1cm of fabric was left intact.The iliac limbs also remain implanted.A bifurcated open surgical graft was sewen to the remaining proximal endurant device and to the endurant limbs.It was also reported since the partial explant of the bifurcated device, the patient has had multiple small bowel resections.The patient is currently receiving comfort care.Per the physician the cause of the endoleak is undetermined.No additional clinical sequalae were provided and the patient will be monitored.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: 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: 17259649
• Report Number: 9612164-2023-03005
• Device Sequence Number: 7882115
• Product Code: MIH
• UDI-Device Identifier: 00613994991133
• UDI-Public: 00613994991133
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2025
• Device Model Number: ETBF2816C166E
• Device Catalogue Number: ETBF2816C166E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 07/05/2023
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female