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

Device Problem Microbial Contamination of Device (2303)

Event Date 11/04/2022

Event Type  Injury  

Event Description

A study alert was received from imedidata database.It was reported to gore that on (b)(6) 2020 this patient underwent endovascular treatment for a common iliac artery aneurysm and was therefore implanted with gore® excluder® aaa endoprostheses as well as gore® excluder® iliac branch endoprostheses.Additionally, it was reported that four gore® viabahn® vbx balloon expandable endoprostheses were implanted into the patient's inferior and superior gluteal arteries during the procedure.With an onset date on (b)(6) 2022, endograft infection secondary to colonic bacteremia requiring treatment was reported.However, the condition was reported to have not yet resolved and it is currently unknown if further treatment has been planned.

Manufacturer Narrative

D10 concomitant medical products: gore® excluder® aaa endoprosthesis.H3-other and h6-b20: the device remains implanted in the patient.Cause investigation and conclusion: a unique device identification number was not provided, therefore the manufacturing date and / or production details cannot be determined.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.This complaint was initiated based on information received through a study alert.The information reported in the complaint does not reasonably suggest a potential malfunction or product packaging and / or labeling issue has occurred.Endograft infection secondary to colonic bacteremia requiring treatment was reported.The reported infection represents a known complication or adverse event that can occur when using stent-graft endovascular devices which can result from several factors.No allegation of device malfunction was indicated with respect to device performance.In the instructions for use the following is stated: potential device or procedure-related adverse events adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoprosthesis or delivery system: infection infection (e.G., aneurysm, device or access sites) based on the event description and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of this incident and assign a root cause.Related manufacturer report on another device: 3007284313-2023-02650.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.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17376135
• MDR Text Key: 319742979
• Report Number: 3013164176-2023-01765
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 07/24/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 92 KG