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

Model Number	ENBF3216C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	07/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.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 8cm in diameter abdominal aortic aneurysm.It was reported that the patient presented to the emergency room with abdominal pain.A ct scan revealed a possible type ia leak.An intervention was performed using heli-fx endoanchors.The heli-fx guide was deflected between 0 and 45 degrees on different endoanchor deployment attempts.It was reported that after deployment of the third endoanchor, the applier had difficulty passing through the guide.A new guide was selected and a total of eleven endoanchors were implanted resolving the type ia endoleak.Per the physician, the cause of the endoleak was due to the patient¿s anatomy; proximal aortic neck dilatation.Per the physician, the cause of the insertion difficulty was due to a kink in the tip of the hel-fx guide that occurred during the procedure.No additional clinical sequelae were reported and the patient is fine.

• 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: 6744549
• Report Number: 2953200-2017-01171
• Device Sequence Number: 10925879
• Product Code: MIH
• UDI-Device Identifier: 00613994762443
• UDI-Public: 00613994762443
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• 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
• Report Date (Section B): 07/02/2017

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: 01/24/2013
• Device Model Number: ENBF3216C124E
• Device Catalogue Number: ENBF3216C124E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2017
• Initial Report FDA Received Date: 07/26/2017
• 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: 70 YR