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

Model Number	ETLW1610C199E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the cause of the left limbs occluding is unknown.No obvious stent graft kinks or compression was observed along the length of the left limbs.The occluded left limb diameter ranged from 12 ¿ 13mm id from bifurcate flow divider to ~4cm distal to the gate ring, and narrowed to 6.5 ¿ 7mm id within the overlapping left limbs.It is possible that implanting within the tortuous left iliac anatomy may have contributed to the occlusion.The pre-existing vessel thrombus, overlapping devices which reduced the stent graft lumen, and extending into the left external iliac may have also been factors.This may also have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.Concomitant medical products: other relevant device(s) are: product id: etlw1610c156e, serial/lot #: (b)(4), ubd: 26-sep-2020, udi #: (b)(4).Other relevant devices are: etlw1610c156e, s/n: (b)(4), use by date: 2020-09-26, upn #: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 60mm abdominal aortic aneurysm.The left common iliac artery diameter measured 58mm-26mm with mild calcification noted.It was reported that follow up ct identified left limb occlusion in the etlw1610c199e ((b)(4)) & etlw1610c156e ((b)(4)).From review of the ct, the physician noted the left external appeared patent from the collaterals and the patient is asymptomatic.Per the physician the cause of the event was anatomy related likely due to vessel tortuosity.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Correction d10: return date correction h3: device returned to manufacturer.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: 8377286
• Report Number: 2953200-2019-00288
• Device Sequence Number: 19586679
• Product Code: MIH
• UDI-Device Identifier: 00643169467620
• UDI-Public: 00643169467620
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2020
• Device Model Number: ETLW1610C199E
• Device Catalogue Number: ETLW1610C199E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 08/28/2019
• 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: Other
• Patient Age: 74 YR