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

Model Number ENBF3616C170EE

Device Problems Break (1069); Device Expiration Issue (1216); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

An endurant stent graft system was inserted but not implanted in a patient for the endovascular treatment of a 60mm abdominal aortic aneurysm.It was reported that when opening the packaging of the device, the handle was observed to be broken at the distal end of the screw gear.There was no damage noted to the device packaging.The physician elected to use the device, the delivery system was advanced to the intended landing zone, however when the physician attempted to deploy the stent graft the sheath could not be retracted.The physician replaced it with another endurant (36 x 16 x 145mm) stent graft and the operation was completed successfully.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported, and the patient is fine.

Manufacturer Narrative

Films review summary: a still image of a delivery system was provided.The still image shows two breaks in the screw gear.One break is located on one side of the screw gear just distal to the rear grip and the other break is located on the other side of the screw gear approximately 40-50mm from the rear grip.The tray is also visualized however, there does not appear to be any damage in the area of the breaks.The cause of the breaks to the screw gear cannot conclusively be determined however, may have been due to shipping/handling as these breaks would not pass the visual inspection prior to leaving the manufacturing facility.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT 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: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 7132874
• MDR Text Key: 95822553
• Report Number: 2953200-2017-02005
• 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: 01/09/2018

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: 04/25/2019
• Device Model Number: ENBF3616C170EE
• Device Catalogue Number: ENBF3616C170EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2017
• 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
• Patient Age: 73 YR