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

Model Number ENLW1610C95EE

Device Problems Difficult To Position (1467); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary; numerous kinks were observed along the stent graft cover.A severe kink was visible on the mid-section of the graft cover.The graft cover was twisted proximal to the stent stop indicating the device had been torqued.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant limb stent graft was planned to be implanted a patient for the endovascular treatment of a 25mm iliac aneurysm.It was reported that the patient had vascular tortuosity and the stent graft was unable to reach the target area.Deformation of the delivery system was noted.The delivery system was withdrawn, a non-mdt stent graft was used instead and the event was reported to be resolved.As per the physician, the cause of the event is unknown.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

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

Manufacturer Narrative

Film evaluation summary: one (1) photo capturing the tapered tip, stent graft cover and graft was received from the account.Damage to the stent graft cover was evident on the photo.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 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: 7624347
• MDR Text Key: 111839527
• Report Number: 2953200-2018-00868
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 10/03/2018

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: 12/19/2019
• Device Model Number: ENLW1610C95EE
• Device Catalogue Number: ENLW1610C95EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 06/21/2018; 08/10/2018; 08/08/2018
• Supplement Dates FDA Received: 07/12/2018; 09/04/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• 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
• Patient Age: 79 YR