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

Model Number	ETLW1610C156E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Thrombus (2101)
Date of Event	05/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the reported right limb occlusion was confirmed; however, the exact cause could not be determined from the films provided.Pre-implant ct¿s were not provided and the anatomy at implant could not be reviewed.Angiograms at implant were also not available for review; the blood flow dynamics could not be assessed from the ct¿s provided.It is possible that implanting within the highly angulated (70 deg) neck, which also contained thrombus proximal to the implanted devices, may have contributed to the occlusion.Device oversizing may have also been a potential factor.The thrombus/occlusion 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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a 52mm abdominal aortic aneurysm.It was reported that approximately three weeks later the patient presented to er with an occluded right limb of the endograft.A ct confirmed the occlusion.The thrombus was confined to the limb only, with no occlusion present in the main bifurcate.It was reported that the thrombus was very fresh and there were no obvious issues with the stent graft.The patient was taken to surgery and an open thrombectomy was performed.Final angiogram confirmed the occlusion was resolved.Per the physician the cause of the event is undetermined.No additional clinical sequelae were reported and the patient is fine.

• 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: 8648872
• Report Number: 9612164-2019-02051
• Device Sequence Number: 13996492
• Product Code: MIH
• UDI-Device Identifier: 00643169467637
• UDI-Public: 00643169467637
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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: 01/13/2021
• Device Model Number: ETLW1610C156E
• Device Catalogue Number: ETLW1610C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2019
• Initial Report FDA Received Date: 05/29/2019
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 95