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

Model Number	ENBF3216C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	01/29/2018
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 a unknown sized abdominal aortic aneurysm.It was reported that during a routine follow up a type ia endoleak was noted.The patient experienced a pre-operative aneurysm rupture which the physician confirmed as a contained rupture.The patient received treatment with the implantation of an endurant cuff, placed to the sma and another manufactures covered stent into the left renal artery channeling down the aorta opening just passed the distal end of the endurant cuff with full inflow to the left renal artery with retrograde flow noted.The type ia endoleak did not resolve after endurant cuff deployment and ballooning.The physician deployed 17 endoanchors.The endoleak was not resolved and a small type ia endoleak was still visible after endoanchor deployment.As per the physician the cause of the event is aneurysm growth.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Additional information was received for this case: the patient was treated with a 3232x49 cuff along with 17 endoanchors for a type ia endoleak.When the procedure ended there was still was a slight type ia endoleak.The physician performed reintervention.A 32/32/49 cuff was implanted up to sma.Another manufactures covered stent was placed into the left renal artery channeling down the aorta opening just passed the distal end of the endurant cuff with full inflow to the left renal artery with retrograde flow noted.The endoleak was noted as resolved after the second procedure.No additional clinical sequelae were reported and the patient is fine.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: 7285387
• Report Number: 2953200-2018-00269
• Device Sequence Number: 19362068
• 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: P102100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018

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: 04/14/2013
• Device Model Number: ENBF3216C145E
• Device Catalogue Number: ENBF3216C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/27/2018
• 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
• Patient Age: 68 YR