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

Model Number UNK-CV-SR-ENDURANT

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

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Infiltration into Tissue (1931); Ischemia (1942); Liver Damage/Dysfunction (1954); Pneumonia (2011); Renal Failure (2041); Rupture (2208); Obstruction/Occlusion (2422); Abdominal Distention (2601); Pseudoaneurysm (2605)

Event Date 10/05/2022

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled: referral centre experience with infected abdominal aortic endograft explantation khalid et al, eur j vasc endovasc surg (2023) 65, 149e158  https://doi.Org/10.1016/j.Ejvs.2022.10.003 a2: mean age a3: mean gender d6a: exact date of implant unknown g2: citation: authors: wajih khalid,mathilde puges, katherine stenson, charles cazanave, eric ducasse, caroline caradu, xavier berard.Referral centre experience with infected abdominal aortic endograft explantation.European journal of vascular and endovascular surgery volume 65, issue 1, p149-158 2023.Https://doi.Org/10.1016/j.Ejvs.2022.10.0 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.Without return of the product no definitive conclusion can be made regarding the clinical observations.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Endurant stent grafts were implanted on unknown dates.Subsequent explants of endurant and non- mdt stents was completed due to endograft infections.The following adverse events were reported: infected endograft,  explant, rupture, aorto-enteric fistulae, vascular haemorrhage, lower limb ischaemia,  renal artery occlusion, peri-graft collection, pseudoaneurysm,  gastrointestinal mesenteric ischaemia, cholecystitis,  gastrointestinal bleeding, gastrointestinal tract leak, fascial disruption, delayed wound healing, abdominal compartment syndrome, hepatic encephalopathy,  renal aki, urinary tract infection,  hydronephrosis,  hospital acquired pneumonia, delirium.Patient death was reported.Within 30 days, 90 day and one year follow up.There was no information to suggest any medtronic device failure caused or contributed to a death. .

• Brand Name: ENDURANT 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: 18933689
• MDR Text Key: 338029639
• Report Number: 9612164-2024-01266
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

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-ENDURANT
• Device Catalogue Number: UNK-CV-SR-ENDURANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/19/2024
• 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 H11...
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male