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

Model Number ETEW2424C82EE

Device Problems Failure To Adhere Or Bond (1031); Kinked (1339); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2018

Event Type  malfunction  

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 ruptured unknown size abdominal aortic aneurysm.It was reported that the endurant ii limb etew2424c82ee delivery system was not smooth.As per the vascular surgeon, the stent was also reported to have being shortened at the distal end on delivery and that there was possibly less seal than desired at the distal end.As per the interventional radiologist, this was not apparent, and it was felt that the distal end looked standard.No leak was reported.The physician attributed the cause of the event to the delivery system.The event has been reported as being resolved.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Device evaluation summary: the distance between the tip and stent stop was measured at 81mm.Resistance was noted retracting the external slider.The handle was opened; one wing of the t-tube had detached and was moving freely inside the slider.Stress marks were observed at the detachment site.Stress marks were visible on the second wing which remained attached.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: ENDURANT II EXTENSION 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: 7518170
• MDR Text Key: 108498767
• Report Number: 2953200-2018-00717
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2019
• Device Model Number: ETEW2424C82EE
• Device Catalogue Number: ETEW2424C82EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 07/25/2018; 08/08/2018
• Supplement Dates FDA Received: 07/26/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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