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

Model Number PLC161200

Device Problems Complete Blockage (1094); Device Stenosis (4066)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 01/24/2023

Event Type  Injury  

Manufacturer Narrative

H6-code b14: a review of the manufacturing records indicated lot met all pre-release specifications.H6-code b20 and h3 other: the device remains implanted in the patient.Therefore an evaluation of the actual device could be be performed.H6-code b15: imaging series have been provided for evaluated.The investigation is ongoing.D10 concomitant medical products: gore® excluder® aaa endoprosthesis (catalog rmt281416, sn (b)(6)) 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 (b)(6) 2014, a patient presenting with abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.On (b)(6) 2023, the patient presented with thrombosis of the contralateral leg of the endoprosthesis.On (b)(6) 2023, the patient was treated with a femoral left to right cross over.

Manufacturer Narrative

Cause investigation and conclusion.The incident information was received from a prospective study.The database entries were reviewed and the provided information was captured in sections 2 and 3.A review of the manufacturing records indicated lot met all pre-release specifications.Neither images of the abdomen enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.Therefore the cause of the reported thrombosis 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 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.The physician reported that "there was nothing in particular that caused the thrombosis".No suspect on what might have caused the thrombosis were reported to gore.No allegation of device malfunction, such as stent collapse or structural deformation was indicated with respect to device performance.Therefore the available information reported in the event does not reasonably suggest a potential malfunction has occurred.The reported thrombosis 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 post-operative follow-up and treatment regimen, patient-related risk factors and disease progression.The instructions for use (ifu) for the appropriate region and time-period was reviewed with respect to the complaint detail.The ifu 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: occlusion of device or native vessel.

Manufacturer Narrative

Corrected serial number, udi and catalog number.

Manufacturer Narrative

G section: contact office - manufacturing site corrected to (b)(4).

• 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 WOODY MOUNTAIN B/P; 3750 w kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17101763
• MDR Text Key: 316955283
• Report Number: 3007284313-2023-02542
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132610723
• UDI-Public: 00733132610723
• 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: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2023

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
• Device Expiration Date: 05/31/2017
• Device Model Number: PLC161200
• Device Catalogue Number: RMT281416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 10/20/2023; 11/08/2023; 12/01/2023
• Supplement Dates FDA Received: 10/20/2023; 11/09/2023; 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2014
• 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
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 101 KG