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

Model Number ESBF2814C103E

Device Problems Use of Device Problem (1670); Folded (2630); Device Damaged by Another Device (2915)

Patient Problem Injury (2348)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 37mm diameter abdominal aortic aneurysm.It was reported that during the index procedure the bifurcate contralateral gate did not open fully at deployment.It was noted that due to this cannulation of the contralateral limb was difficult and time consuming.The issue was resolved with the use of the up and over aortic bifurcation snare technique and implant of a limb extension.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT IIS BIFURCATED 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: 7361098
• MDR Text Key: 103144687
• Report Number: 2953200-2018-00407
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439979
• UDI-Public: 00643169439979
• 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
• Report Date: 03/22/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2020
• Device Model Number: ESBF2814C103E
• Device Catalogue Number: ESBF2814C103E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/22/2018
• Date Device Manufactured: 01/22/2018
• 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): Required Intervention
• Patient Age: 66 YR