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

Model Number	ETLW1613C199E
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was attempted implanted in the patient for the endovascular treatment of a type 1b endoleak from prior evar done 5 years before.It was reported that during the index procedure, after inserting the endurant limb through tortuous iliacs arteries, the physician attempted to deploy the device the graft but the graft cover wasn't coming down while deploying.The device was then removed from the patient, where it was noted that the stent ring was protruding through of the graft cover.The procedure was successfully completed with another stent graft.As per the physician the cause of the event can not be determined.No additional clinical sequalae were reported and the patient is fine.
Additional Manufacturer Narrative
Product analysis device decontaminated with cidex-opa pending further device testing to support the final product analysis findings.The device returned with the external slider in the home position.A gap was visible between the graft and the stent stop.The graft cover was kinked over the stent stop.Two stent grafts segments were protruding through the graft cover.It was not possible to deploy the graft using the external slider.The graft cover was cut to expose the proximal stent rings and the graft was manually deployed.A large tear was visible on the graft cover where the stent segments had protruded.The stent segments were raised with no sutures visible at the apex of the segments.The handle was broken down to confirm the correct size stent stop and graft cover were consumed in the manufacturing of the device.The reported deployment/expansion difficulties were 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.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.
Additional Manufacturer Narrative
B5.Additional information received; it was confirmed the ib endoleak affected the etlw1620c124e ((b)(6) ) stent graft.The cause of the ib endoleak as per the physician was continued disease progression of the iliac artery.It was reported the endurant that was attempted to be implanted during the intervention procedure was inspected prior to use.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 II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11840450
• Report Number: 9612164-2021-01939
• Device Sequence Number: 4689048
• Product Code: MIH
• UDI-Device Identifier: 00643169467705
• UDI-Public: 00643169467705
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2023
• Device Model Number: ETLW1613C199E
• Device Catalogue Number: ETLW1613C199E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 05/21/2021; 08/04/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/11/2021; 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR