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

Model Number	ETBF3616C145E
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 62 mm diameter abdominal aortic aneurysm.It was reported that during the index procedure, the nose cone of the delivery system became detached.It was reported that the physician believed the nose cone was compromised during re-sheathing of the stent graft, and that it potentially became kinked at that point.The physician then trapped the detached nose cone with a thoracic stent graft which resolved the event.As per the physician, the cause of the event was user error.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Update: fdp code added on review of file.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Update: fdc code added at investigation completion.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8906044
• Report Number: 9612164-2019-03462
• Device Sequence Number: 2229998
• Product Code: MIH
• UDI-Device Identifier: 00613994991034
• UDI-Public: 00613994991034
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: ETBF3616C145E
• Device Catalogue Number: ETBF3616C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/28/2019; 10/11/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/24/2019; 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR