MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	RLT261216
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735)
Date of Event	07/18/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Udi for gore® excluder® iliac branch component (b)(4).Udi for gore® excluder® internal iliac component (b)(4).Udi for gore® excluder® contralateral leg component (b)(4).Udi for gore® excluder® contralateral leg component (b)(4).The review of the manufacturing records verified that the lots involved in this event met all pre-release specifications.The devices were discarded at the facility and are therefore not available for investigation.Please note: this report is associated with mfr report # 2953161-2018-00076.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018, this patient underwent endovascular treatment for an isolated aneurysm of the right common iliac artery in the absence of an abdominal aortic aneurysm.The patient was therefore treated with gore® excluder® aaa endoprostheses as well as gore® excluder® iliac branch endoprostheses.On (b)(6) 2018, computed tomography imaging identified an infection around the iliac branch endoprostheses.An abscess is held responsible for having spread the bacterial infection to the pelvic region.There was no infection known to have existed in the area of treatment prior to device implant.On (b)(6) 2018, all gore® excluder endoprostheses were reported to have been explanted due to the infection.On (b)(6) 2018, it was reported that the patient has died.The exact date and cause of death are currently unknown.
Additional Manufacturer Narrative
Changed type of reportable event.Please note: this report is associated with mfr report # 2953161-2018-00076.
Event or Problem Description
On (b)(6) 2018, all gore® excluder endoprostheses were reported to have been explanted due to the infection.The next day, on (b)(6) 2018, the patient reportedly expired.As a complication in the aftermath of the explant procedure, the combination of severe sepsis and hypotension was thought to be the probable cause of death.
Additional Manufacturer Narrative
Adverse event or problem: outcomes attributed to adverse event: corrected selection.Date of death: added date.Please note: this report is associated with mfr report # 2953161-2018-00076.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7815797
• Report Number: 3007284313-2018-00238
• Device Sequence Number: 11374197
• Product Code: MIH
• UDI-Device Identifier: 00733132622429
• UDI-Public: 00733132622429
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2018

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: 01/30/2020
• Device Catalogue Number: RLT261216
• Device Lot Number: 15939059
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 11/06/2018; 11/08/2018
• 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: Death; Hospitalization; Required Intervention
• Patient Age: 62 YR