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

Model Number	ENLW1620C93E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Injury (2348)
Date of Event	06/05/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: enlw1620c93e, serial/lot #: (b)(4), ubd: 24-apr-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Heli-fx endoanchors were used in the treatment of migration in a previously implanted aneurx stent graft system in a patient.One talent aortic cuff was also implanted together with bilateral endurant iliac cuffs during the procedure.The aaa diameter was noted as 43mm.The proximal aortic neck measurers 28mm with the proximal aortic angle of 20 degrees.It was reported that one day post index procedure, the patient experienced hypotension.Medication was administered and the hypotension resolved.Per the investigator the cause of the event was possibly related to the index procedure.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7897177
• Report Number: 2953200-2018-01326
• Device Sequence Number: 168392
• Product Code: MIH
• UDI-Device Identifier: 00613994761927
• UDI-Public: 00613994761927
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/19/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2014
• Device Model Number: ENLW1620C93E
• Device Catalogue Number: ENLW1620C93E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 12/19/2018
• 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: 74 YR
• Patient Weight: 91