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

Model Number ENLW1613C95EE

Device Problems Activation, Positioning or Separation Problem (2906); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2023

Event Type  malfunction  

Event Description

An endurant stent graft limb was attempted to be implanted during the endovascular treatment of a 250 mm thoracoabdominal  aneurysm  and a 350mm length dissection. it was reported that the preoperative preparation went well. during the index procedure, when the contralateral iliac stent graft limb was attempted to be deployed, the tip of the stent did not open and a gelatinous substance was observed.  another stent was implanted with no issues.Per the physician, the cause of the event is unknown.No additional sequelae was reported 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.

Manufacturer Narrative

Additional information: per the physician, the cause of the events was due to product issue.It was reported there was no issues noted during device preparation that led to attempting to deploy the stent graft in vitro.The gelatinous substance was noted to have fallen out from the device.When the stent was deployed in vitro, transactional cuts to the fabric were visible between the bare stent apexes.These cuts to the fabric were noted when the stent was open.Photo evaluation summary: three (3) photos were received from the account.There is no blood visible on the delivery system, graft or underneath the graft cover indicating attempted deployment.A gap is visible between the taper tip and the graft cover/graft indicating the graft is moving distally as the graft cover is retracted.There appears to be some damage to the end of the stent stop.The next photo captures the expanded graft after the graft cover has been cut away.The first stent ring is restricted and not expanded.It is not possible to determine what is restricting the stent ring from the photo received.The final photo captures the taper tip with residue/material visible on the surface.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.

Manufacturer Narrative

Product analysis conclusion: the device returned in the product tray pouches and shelf carton.There was no blood visible on the surface of the device or inside the graft cover or on the stent.The stent had been deployed and the first proximal stent ring was fully expanded.There was no substance visible on the graft.A transectional cut was visible between the second and third stent rings.Two stent rings were missing.Device decontaminated with cidex-opa pending, further device testing to support the final product analysis findings.The delivery system returned with the external slider in the home position.The graft cover had been cut to allow deployment of the graft.Heavy yellow staining was visible on the graft fabric around the proximal stent ring.Staining was visible on the fabric along the length of the stent.The reported deployment/expansion difficulties could not be confirmed, based on the analysis of the returned device.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 ILIAC 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: 16155800
• MDR Text Key: 307302897
• Report Number: 9612164-2023-00173
• 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,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2023
• Device Model Number: ENLW1613C95EE
• Device Catalogue Number: ENLW1613C95EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 01/13/2023; 02/08/2023
• Supplement Dates FDA Received: 02/02/2023; 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2021
• 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