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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Bacterial Infection (1735)

Event Date 05/12/2023

Event Type  Injury  

Event Description

It has been reported to gore that the patient presented with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis on (b)(6) 2023.It remains unknown if apposition/seal of the device to the aortic wall was achieved at the completion of the procedure.Reportedly on (b)(6) 2023 a gore® viabahn® endoprosthesis with propaten bioactive surface has been implanted in order to treat a type ib endoleak originating from the right limb.No aneurysm growth has been reported.

Manufacturer Narrative

A unique device identification number was not provided, therefore the manufacturing date and/or production details cannot be determined.H6-b20 and h3-other: the device remains implanted in the patient.Therefore a device evaluation could not be performed.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.

Manufacturer Narrative

Cause investigation and conclusion: a request was sent to the physician to further clarify details of the implant procedure, serial number of the device, and patient symptoms, and provide clinical images for evaluation.A unique device identification number was not provided, therefore the manufacturing date and/or production details cannot be determined.No further information was provided neither on details of the implant procedure, nor patient symptoms.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.Therefore the cause of the reported type 1b endoleak could not be independently confirmed during the investigation.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.No clinical images have been provided to gore for evaluation.The available information reported in the event description does not reasonably suggest a potential malfunction issue has occurred.It remains unknown if the reported infection caused of contributed to the endoleak.The reported endoleak represents a known complication or adverse event that can occur when using stent-graft endovascular devices and can arise as a result of a multitude of factors, including intra-procedural technical considerations, patient-related risk factors and disease progression.No allegation of device malfunction, such as structural deformation or device migration was indicated with respect to device performance.The instructions for use (ifu) for the appropriate region and time-period was reviewed.It states the following: 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: endoleak; no potential new or different reasonably foreseeable risks related to the device or its use were identified based on this event.Ongoing risk/benefit assessment affirms risk acceptability based on current performance.No corrective measures are needed as a result of this event.Gore will continue to monitor post-market data closely to ensure that the risk assessment remains accurate.Considering the incident description, no further information was provided to gore, and the results of this investigation, this occurrence did not warrant remedial, corrective or preventative action in addition to no field safety action.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17610059
• MDR Text Key: 321803807
• Report Number: 3007284313-2023-02721
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 11/09/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male