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

Model Number UNK-CV-SR-ENDUR-II

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Renal Failure (2041); Obstruction/Occlusion (2422); Embolism/Embolus (4438)

Event Date 07/15/2023

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: hon-lai chan, dimitrios d.Papazoglou, silvan jungi, salome weiss, daniel becker, drosos kotelis, vladimir makaloski.Fenestrated physician-modified endografts for preservation of main and accessory renal arteries in juxtarenal aortic aneurysms.Journal of clinical medicine 4708 2023.10.3390/jcm12144708 earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.A.2 / a.3 average.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.

Event Description

Endurant ii stent grafts were physician modified for the preservation of main and accessory renal arteries in juxtarenal aortic aneurysms.37 patients were included in the study and the procedures took place on unknown dates over a 4 year period.A juxtarenal aaa was defined  as an aneurysm extending up, but not involving, the renal arteries with a short infrarenal neck 10 mm. the standard length used for aortic cuffs was 49 mm, and 145 mm or 166 mm for bifurcated endografts.The endurant stent grafts were partially deployed under sterile conditions, the fenestrations were created using a scalpel which were then reinforced using a non mdt wire and sutures.  the following adverse events were reported;  acute kidney injury, access site bleeding, infection, groin fistula, occlusion, aneurysm enlargement , embolism, re-intervention. .

• Brand Name: ENDURANT II 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: 18198754
• MDR Text Key: 328891350
• Report Number: 9612164-2023-05490
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2023

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: UNK-CV-SR-ENDUR-II
• Device Catalogue Number: UNK-CV-SR-ENDUR-II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 11/23/2023
• 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; Other
• Patient Age: 75 YR
• Patient Sex: Male