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

Model Number ETLW1620C156E

Device Problems Activation, Positioning or Separation Problem (2906); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

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 ii stent graft system was inserted in the patient for the endovascular treatment of a 5.5 cm abdominal aortic aneurysm.Prior to the implant it was noted that the back of the outer box had damage to it, however the sterile pouch did not have any damage and the physician elected to use the device as it was the correct size that was needed.The stent graft delivery system was advanced to the intended landing zone.The physician was rotating the handle to deliver the stent graft however the graft cover would only retract to the edge of the graft fabric.Tension built up in blue handle until it begun to twist in the opposite direction due torque build up.The graft cover reportedly would not retract any further.The device was removed from the patient and another device was implanted successfully.The initial delivery system was then taken apart and the graft cover still could not be deployed on the back table.The graft cover was reportedly bunching up in the handle.The physician stated that the event was related to the device.No clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Film evaluation summary: the reported damage to the original packaging/outer box was confirmed.However, it was unclear if the damage to the outer box/original packaging has any relationship to the deployment difficulty.The exact cause of the deployment difficulty could not be conclusively determined from the films, images, and video provided.

Manufacturer Narrative

Device evaluation summary: the reported inability to deploy the stent graft cannot be confirmed as the device was returned in a state that prohibited a thorough evaluation.From the examination of the returned components, all measurements were within manufacturing specifications.The exact cause of the event could not be conclusively determined.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.

Manufacturer Narrative

Corrected information: sex, date of birth, no eval explain code.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: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 6108176
• MDR Text Key: 60077073
• Report Number: 2953200-2016-01977
• Device Sequence Number: 1
• Product Code: MIH
• 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,Followup,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2018
• Device Model Number: ETLW1620C156E
• Device Catalogue Number: ETLW1620C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2016
• 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: 78 YR
• Patient Weight: 95