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

Model Number ENLW1616C80EE

Device Problems Kinked (1339); Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2017

Event Type  malfunction  

Manufacturer Narrative

Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant stent graft system was attempted for use in a patient for the endovascular treatment of abdominal aortic stenosis.There was no damage to the product packaging.A bifurcate stent graft was not implanted.It was reported that when inserting the guide wire, the physician found the guide wire could not cross the delivery system.The physician checked and observed that the inner catheter of the delivery system was kinked.It was replaced with another stent graft of the same model and the operation was completed successfully.This reportedly resolved the event.The physician stated that the cause of the event was device related.The physician didn't believe that the kink was present prior to the device being inserted into the patient.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Device evaluation summary: the complaint was confirmed; there was slight resistance when passing the steering wire through the delivery system due to a small curve in the guidewire lumen.The root cause of the minor curve could not conclusively be determined.However, the event likely occurred after the device was prepped, as no kink was seen when removed from packaging.To when the attempt to insert the device into the patient was being performed.It was noted during analysis that the steering wire could pass through the entire delivery system.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: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 6892984
• MDR Text Key: 87460352
• Report Number: 2953200-2017-01483
• 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
• Report Date: 10/27/2017

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: 02/27/2019
• Device Model Number: ENLW1616C80EE
• Device Catalogue Number: ENLW1616C80EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 10/02/2017
• Supplement Dates FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2017
• 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: 88 YR