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

Model Number ENBF2816C145EE

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

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

An endurant stent graft was implanted during the emergent endovascular treatment of a threatened ruptured 70mm aaa.No approach stenosis or calcified thrombus was found in preoperative examination.It was reported during the index procedure the physician activated the hydrophilic coating however it was difficult to insert the stent graft.The delivery system was withdrawn and the hydrophilic coating was activated again.The stent was deployed after a difficult delivery.Difficulties were then encountered when attempting to withdraw the delivery system and the physician was unable to withdraw due to a suspected vasospasm in the patient.After the anesthesiologist administered medication the physician waited 15 minutes before withdrawing the delivery system successfully.Per the physician the cause was due to the failure of the hydrophilic coating on the device.No additional sequelae were reported and the patients is fine.

Manufacturer Narrative

Device evaluation summary: device decontaminated with cidex-opa pending further device testing to support the final product analysis findings.The delivery system returned for analysis with the external slider open and graft cover fully retracted.No difficulty was experienced advancing and retracting the graft cover.Blood was visible on the backend wheel screw gear threads, and the while had partially skipped off the threads.Additional decontamination was performed to remove excess blood and the backend wheel was removed.Excessive stress marks were visible on the wheel tabs with no deformation noted to the dowels.Severe damage was observed to the screw gear threads underneath the backend wheel.The handle was disassembled and the middle member lock components, stent stop t-tube and strain relief were confirmed as 20f size.The reported coating issue could not be confirmed through analysis.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.

• Brand Name: ENDURANT BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 18985593
• MDR Text Key: 338685980
• Report Number: 9612164-2024-01476
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ENBF2816C145EE
• Device Catalogue Number: ENBF2816C145EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2023
• 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