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

Model Number ETLW1610C124E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Pain (1994); Weakness (2145)

Event Date 04/18/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of a 42mm abdominal aortic aneurysm.One day previously the patient had a right femoral endarterectomy performed.The evar procedure reportedly went well and the patient was discharged the next day.Post-operatively nine days post the index procedure, the patient presented with leg pain and weakness.The patient had weak pulses.A ct was performed which showed a limb occlusion.The images revealed that the right endurant limb is severely compressed through the distal aorta.It was noted the distal aortic measured only 16 mm in diameter.As per the physician the cause of the event is the right limb being compressed through the distal aorta.No additional clinical sequalae were provided and the patient will be monitored.

Manufacturer Narrative

Additional information received: it was reported that the right femoral endarterectomy was performed during the evar procedure and not the day previously.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 10000147
• MDR Text Key: 190502577
• Report Number: 9612164-2020-01684
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169467644
• UDI-Public: 00643169467644
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2022
• Device Model Number: ETLW1610C124E
• Device Catalogue Number: ETLW1610C124E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2020
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 05/25/2020
• Date Device Manufactured: 01/30/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 78 YR