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

Model Number ETLW1624C156E

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 01/31/2018

Event Type  Injury  

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 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7317535
• MDR Text Key: 101631238
• Report Number: 2953200-2018-00328
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169467491
• UDI-Public: 00643169467491
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2019
• Device Model Number: ETLW1624C156E
• Device Catalogue Number: ETLW1624C156E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 06/20/2018; 08/08/2018
• Supplement Dates FDA Received: 08/08/2018; 10/04/2018
• Date Device Manufactured: 10/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR