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

Catalog Number RLT281218K

Device Problem Contamination (1120)

Patient Problem Bacterial Infection (1735)

Event Date 06/23/2021

Event Type  Death  

Manufacturer Narrative

According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to  infections.

Event Description

The following information was reported to gore: on an unknown date a patient underwent endovascular treatment with gore® excluder® aaa and iliac branch endoprostheses.Several weeks later the patient exhibited pain and infection leading to explantation of the devices.Several days later the patient expired.

Event Description

The following information was reported to gore: on (b)(6) 2021, a patient underwent endovascular treatment of an aorto-iliac aneurysm with gore® excluder® aaa and iliac branch endoprostheses.The procedure was uneventful and the patient was discharged within 24 hours.The patient had a history of covid19 for 7 days but he was oligosymptomatic (mild runny nose and one day of coughing).Approximately 45 days later the patient presented pain in the left iliac fossa compatible with psoitis or diverticulitis, but without fever or malaise.He presented with worsening of the condition and underwent a ct that showed retroperitoneum and intraaneurysmal abscess.He underwent exploratory laparotomy, with a large amount of pus in the retroperitonium, inside the aneurysmal sac and already in the intraperitoneal cavity.The devices were explanted and the entire aortoiliac segment was resected, followed by an axillo-bifemoral bypass.Eighteen hours later the patient expired in the icu.

Manufacturer Narrative

B.5.Updated: h.6.Results code 1: 213 the following device lots met all pre-release manufacturing and sterilization specifications: udi: (b)(4), sn#: (b)(6), udi: (b)(4), sn#: (b)(6), udi: (b)(4), sn#: (b)(6), udi: (b)(4), sn#: (b)(6).

Manufacturer Narrative

The cause of death remains unknown, however the report type has been changed to "death" as it could possibly be due to device infection.The date of death is estimated as it was stated the death was approximately 45 days post-operatively.

Manufacturer Narrative

Updated sections a, b and e.

Manufacturer Narrative

Updated: h1/h2: death.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: heidi inskeep ; 1505 n. fourth street; phoenix, AZ 86005 ; 9285263030
• MDR Report Key: 12071040
• MDR Text Key: 266955249
• Report Number: 3007284313-2021-01480
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/22/2022

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: 05/08/2021
• Device Catalogue Number: RLT281218K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 09/28/2021; 09/28/2021; 11/24/2021; 02/21/2022
• Supplement Dates FDA Received: 09/28/2021; 10/05/2021; 11/24/2021; 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention; Other; Death
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 80 KG