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

Model Number	ETLW1624C156E
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system.Other relevant devices are: esbf2514c103e , s/n: (b)(4); use by date: 05-dec-2019; upn # (b)(4)etlw1616c156e , s/n: (b)(4); use by date: 31-oct-2019; upn # (b)(4).Intervention/treatment performed was reported.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft system was implanted for the endovascular treatment of an unknown endovascular treatment.It was reported after the index procedure, the patient phoned technical services to report that they have experienced a metallic taste in their mouth and a loss of appetite.The cause of the event is undetermined.No additional clinical sequalae were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II 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: 7317535
• Report Number: 2953200-2018-00328
• Device Sequence Number: 16545505
• Product Code: MIH
• UDI-Device Identifier: 00643169467491
• UDI-Public: 00643169467491
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 10/17/2019
• Device Model Number: ETLW1624C156E
• Device Catalogue Number: ETLW1624C156E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 06/20/2018; 08/08/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 08/08/2018; 10/04/2018
• 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: Other
• Patient Age: 59 YR