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

Model Number ESBF3214C103EE

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 08/29/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant stent graft system was implanted in the patient for a chevar endovascular treatment of a 43mm aaa during the procedure it was reported the stent graft system was delivered as per ifu but when attempting to pull the device into the proximal part of the main body it got hung up on one of the suprarenal struts.Rotation was applied and the device continued to get stuck on the suprarenal stent.The non mdt stiff wire was changed to a 0.035" non mdt wire which brought the tip of the device away from the opposite wall and allowed it to pass into the main body without complication.When capturing the outer sheath of the main body delivery system (grey to blue) as per the ifu and it was getting caught around the aortic bifurcation.The decision was made to change the wire back to the intial one but the wire would not pass any further than approx.2cm into the hub of the main body delivery system.The physician then began dismantling the delivery system when the hub and the inner wire lumen snapped off.The 0.035" wire was then able to pass into the wire lumen and up into the abdomen and the delivery system was attempted to be pulled out but the top cap and with metal wire lumen stayed stuck inside the patient the rest of the delivery system was retrieved by cut down.The patient received a 3 piece graft then with endoanchors to complete the procedure per the physician the cause of the event could not be determined no additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Additional information received: it was confirmed that the top cap and metal wire lumen were successfully removed at the time of the procedure (before the ipsilateral limb extension was delivered).It was removed by performing a cut down.The patient was doing well a day after the procedure and the physician has had no further follow-up.Product analysis device decontaminated with cidex-opa pending further device testing to support the final product analysis findings.The delivery system returned with the handle components disassembled.Multiple kinks were observed along the graft cover.The spiral tubing was kinked and deformed along its length distal to the stent stop.The inner member had broken 1.5cm distal to the t-bar with the break site jagged and uneven.The reported detachment can be confirmed through analysis.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.

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 IIS BIFURCATED 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: 12480899
• MDR Text Key: 271677477
• Report Number: 9612164-2021-03559
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 11/15/2021

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 Expiration Date: 12/04/2022
• Device Model Number: ESBF3214C103EE
• Device Catalogue Number: ESBF3214C103EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 09/17/2021; 10/20/2021
• Supplement Dates FDA Received: 10/14/2021; 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2020
• 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: 90 YR
• Patient Sex: Male
• Patient Weight: 70 KG