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

Model Number	ENBF3616C166E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/26/2019
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 stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that approximately 6 years 10 months post implant, a follow up ct identified the bifurcate had migrated distally with loss of seal seen proximally.There was no type ia endoleak noted.It was noted the patient was asymptomatic.The following day, the physician performed an open repair and the device was explanted.Per the physician, the cause of the event is undetermined.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Additional information received reported that the stent graft had migrated to far distally into the aneurysm sac to use a cuff.There was no aneurysm enlargement reported.Device evaluation summary: the devices were returned relatively intact, with the exception of the suprarenal stents which had been transected proximally, and several burn holes which were noted on the contra limb and extension; all likely to have occurred during the explant.No stent fractures, fabric tears, or significant suture cuts were observed on any of the returned devices.A 10mm diameter iliac stent was found positioned inside the distal end of the contra limb extension.From the examination of the returned devices and limited clinic information returned, the exact cause of the reported loss of proximal seal leading to the stent graft migration could not be determined.Patient anatomy and films were not available for review, and the in-vivo configuration of the stent graft during the 82-month implant duration could not be assessed.It is possible that disease progression (aortic neck dilatation) may have led to the loss of proximal seal and eventual stent graft migration.The reason for implanting the bare metal stent could not be determined.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: 8815532
• Report Number: 9612164-2019-03010
• Device Sequence Number: 16900949
• Product Code: MIH
• UDI-Device Identifier: 00613994762375
• UDI-Public: 00613994762375
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

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: 06/21/2013
• Device Model Number: ENBF3616C166E
• Device Catalogue Number: ENBF3616C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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: 67 YR
• Patient Weight: 85