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

Model Number ETCF3636C49E

Device Problems Device Damaged by Another Device (2915); Positioning Problem (3009)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 12/06/2023

Event Type  Injury  

Event Description

An endurant iis stent graft system was implanted during the emergent endovascular treatment of a 71mm infra-renal impending rupture.The proximal aortic neck diameter was noted as 30mm and was 20mm in length.Severe neck angulation and vessel tortuosity, accompanied by moderate to severe vessel calcification was noted.It was reported during the index procedure, post-implantation of the bifurcated stent graft and limb stent grafts, an angiogram identified a type ia endoleak.An attempt was made to implant an aortic cuff (b)(6), but due to the complexity of the anatomy and the existing endograft, the cuff was withdrawn before deployment from the right femoral artery.Resistance during removal was encountered and the patient's blood pressure dropped.It was determined that the right external iliac had ruptured.A right iliac bypass was performed to repair and stabilize the injury.The patient then became stable after the repair.A replacement aortic cuff (b)(6) was successfully implanted, resolving the type ia endoleak per the physician the cause of the type ia endoleak is undetermined.The cause of the rupture was due to the complexity of the anatomy and the existing endograft.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.

• Brand Name: ENDURANT II EXTENSION CUFF
• 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: 18290564
• MDR Text Key: 330041088
• Report Number: 9612164-2023-05839
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: ETCF3636C49E
• Device Catalogue Number: ETCF3636C49E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/08/2023
• Date Device Manufactured: 04/20/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR
• Patient Sex: Female