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

Catalog Number RLT311415

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Sepsis (2067)

Event Date 01/08/2024

Event Type  Injury  

Manufacturer Narrative

D10: gore® excluder® aaa endoprosthesis stent graft contralateral leg plc201000 lot no.25658188 gore® excluder® aaa endoprosthesis stent graft contralateral leg plc201200 lot no.25515403 h3: device remains implanted.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It was reported that on december 22, 2022, a patient presenting with an abdominal aortic aneurysm measuring 5.7 cm was treated with a gore® excluder® aaa endoprosthesis.In january, 2024, the patient was admitted to the hospital presenting with sepsis, temperature spikes, weight loss, acute kidney injury, covid, a positive blood culture for s.Aureus and negative echocardiogram results for infective endocarditis.Maximum abdominal aortic aneurysm was measured at 5 cm.No endoleak was detected.On january 8, 2024, computed tomography (ct) showed a maximum aortic aneurysm diameter of 5 cm.On january 24, 2024, the patient underwent ct imaging due to a persistent fever.Mild linear hypodensity adjacent to the posterior / posterior medial aspect of the treated area of the proximal left common iliac artery.On january 25, 2024, the patient underwent magnetic resonance imaging (mri) of a shoulder arthroscopy performed in 2023.The physician suspected inflammatory arthropathy/septic arthritis.The patient started receiving antibiotics.On february 6 and 7, the patient presented with new mild periaortic inflammatory fat stranding suggestive of aortitis or device infection.Mild aortic sac enhancement, with surrounding fat stranding and minimal lymphadenopathy suggestive of inflammation was also reported.On (b)(6) the physician reported a probable infection of the stent wire material in the implanted device in the treatment area of the proximal left common iliac aorta.On march 5, device infection was confirmed in positron emission tomography (pet).The patient will continue antibiotics for the next three months.The patient remained admitted in the hospital.The cause of the sepsis us unknown.

Manufacturer Narrative

Corrected description and medical device problem code.

Event Description

It was reported that on (b)(6), 2022, a patient presenting with an abdominal aortic aneurysm measuring 5.7 cm was treated with a gore® excluder® aaa endoprosthesis.In (b)(6), 2024, the patient was admitted to the hospital presenting with sepsis, temperature spikes, weight loss, acute kidney injury, covid, a postive blood culture for s.Aureus and negative echocardiogram results for infective endocarditis.Maximum abdominal aortic aneurysm was measured at 5 cm.No endoleak was detected.On (b)(6), 2024, computed tomography (ct) showed a maximum aortic aneurysm diameter of 5 cm.On (b)(6), 2024, the patient underwent ct imaging due to a persistent fever.Mild lienar hypodensity adjacent to the posterior / posterior medial aspect of the treated area of the proximal left common iliac artery.On (b)(6), the patient underwent magnetic resonance imaging (mri) of a shoulder artroscopy performed in 2023.The physician suspected inflammatory artropthy/septic arthritis.The patient started receiving antibiotics.On (b)(6), the patient presented with new mild periaortic inflammatory fat stranding suggestive of aortitis or device infection.Mild aortic sac enhancement, with surrounding fat stranding and minimal lymphadenopathy suggestive of inflammation was also reported.On (b)(6) the physician reported a probable infection of the stent wire material in the implanted device in the treatment area of the proximal left common iliac aorta.On (b)(6), device infection was confirmed in positron emission tomography (pet).The patient will continue antibiotics for the next three months.The patient remained admitted in the hospital.The cause of the sepsis us unknown.

• 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: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18958772
• MDR Text Key: 338351323
• Report Number: 3007284313-2024-03126
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132619085
• UDI-Public: 00733132619085
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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 Catalogue Number: RLT311415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 93 KG