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

Model Number	ETBF2316C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Pleural Effusion (2010); Renal Failure (2041); Urinary Tract Infection (2120); Injury (2348); Blood Loss (2597)
Date of Event	11/14/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system.Other relevant device(s) are: product id: etlw1616c82e, serial/lot #: (b)(4), ubd: 16-jul-2015, udi#: (b)(4); product id: etlw1616c124e, serial/lot #: (b)(4), ubd: 06-sep-2015, udi#: (b)(4); product id: etlw1616c93e, serial/lot #: (b)(4), ubd: 27-sep-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A heli-fx endoanchoring system was used as an accessory device due to concern for late failure in a patient for the endovascular treatment of a 56mm abdominal aortic aneurysm.An endurant ii stent graft system was also implanted during the procedure.Nine endoanchors were successfully implanted from the main body of the endograft to the proximal neck.It was reported post the index procedure the patient developed bilateral incisional pain which was treated with medication.Ecchymosis around the incision site was observed the following day which resolved without treatment.One day post the index procedure bleeding and anemia were reported.This event was treated with a blood transfusion and confirmed as resolved.On the same date the patients urinary output was decreased and a uti was diagnosed the following day.Treatment with medication and ivf replacement resolved this event.A pleural effusion was also diagnosed on this day.It is reported that this resolved without treatment.The above reported events were determined to be related to the index procedure.Approximately one year later the patient developed thrombocytopenia and care has since transferred to another group.No additional clinical sequelae were reported.

• Brand Name: ENDURANT II 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: 7657918
• Report Number: 2953200-2018-00935
• Device Sequence Number: 19424339
• Product Code: MIH
• UDI-Device Identifier: 00613994991218
• UDI-Public: 00613994991218
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: 09/16/2015
• Device Model Number: ETBF2316C166E
• Device Catalogue Number: ETBF2316C166E
• Device Lot Number: V04117595
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/03/2018
• 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 Weight: 73