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

Model Number	ETLW1620C93E
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
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 limb was intended to be implanted as part of the endovascular treatment of a 55mm abdominal aortic aneurysm.It was reported during the index procedure, the limb would not fully deploy.It was said only one stent was released, so the device was able to be retrieved through the sheath and a different device was used to complete the case.As per the physician the cause of the event was a device malfunction.No additional clinical sequelae were provided, and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported limb deployment could not be assessed on the film provided; therefore the cause of the event could not be determined.Procedural angiograms showing attempts to deploy the device were not received for thorough analysis of the event.Analysis of the returned films did not reveal any obvious anatomical anomalies that may have led to the reported deployment issues.A device issue cannot be ruled out as a potential cause.The delivery system has been returned for investigation and is pending analysis.The results will be summarized in a separate report.Device evaluation summary: the device returned with the two graft stent rings deployed.The gap between the front grip and external slider was measured at 11.7cm.The gap between the taper tip and the graft cover tip was 4.1cm.The distal end of the stent stop was deformed by the graft.Stretching was observed on the distal side of the graft cover bond.On rotation of the external slider the stretching became more pronounced.The stent did not deploy further on rotation of the external slider.The 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.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10710458
• Report Number: 9612164-2020-04024
• Device Sequence Number: 16937421
• Product Code: MIH
• UDI-Device Identifier: 00643169467514
• UDI-Public: 00643169467514
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Report Date (Section B): 12/09/2020

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: 06/23/2021
• Device Model Number: ETLW1620C93E
• Device Catalogue Number: ETLW1620C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 100