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

Model Number	ENBF3216C145E
Medical Device Problem Codes	Leak/Splash (1354); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant devices are: enlw1620c124e, s/n: (b)(4); use by date: 03-apr-2014; upn # (b)(4); enlw1624c82e , s/n: (b)(4); use by date: 06-mar-2014; upn # (b)(4).Date of event unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of an unknown size diameter abdominal aortic aneurysm.It was reported that on an unknown date a type iii endoleak was observed in the patient.It is noted that there was no migration of the stent and that the aorta had expanded past the nominal diameter of the device.It was noted that it was unclear if the type iii separation was a consequence of a previous intervention preformed for a separate event.On an unknown date, intervention was performed for the type iii endoleak by the implantation of a limb component to bridge the gap.It is noted that the event has been resolved.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary; the cause of the type iii junctional separation between the contra limb and bifurcate gate could not be determined.The amount of initial contra limb overlap within the gate is unknown and the aneurysm morphology at implant is unknown.It is possible that the limb detachment was caused by aneurysm morphology changes leading to increased limb angulation and eventual detachment.Although a clear type iii junctional endoleak could not be confirmed, it is possible that the aaa sac may have been pressurized via this limb detachment.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT 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: 7172225
• Report Number: 2953200-2018-00037
• Device Sequence Number: 19086815
• Product Code: MIH
• UDI-Device Identifier: 00613994762436
• UDI-Public: 00613994762436
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 03/12/2014
• Device Model Number: ENBF3216C145E
• Device Catalogue Number: ENBF3216C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 05/21/2018
• 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