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

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

Date and details of the procedure and patient information was requested but the physician cannot remember the case.Patient information could not be obtained, therefore the gore reference number was used is the patient identifier.The serial number remains unknown.Therefore a review of the manufacturing records could not be performed.Reportedly, clinical x-ray images are not available for evaluation.The device was successfully implanted and the delivery system was discarded at the facility.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.Two pictures of a delivery catheter taken on (b)(6) 2016, have been provided by the physician for evaluation.As a best estimate this date is used as the event date.The investigation has revealed that the device depicted in the pictures is not the delivery catheter of a gore® viabahn® endoprosthesis as reported by the physician, but most likely the delivery catheter of a contralateral leg endoprosthesis of a gore® excluder® aaa endoprosthesis.Therefore, this device is reported as the affected device.Codes b15 and c070603: the device(s) was not returned for analysis.The investigation was concluded using the provided pictures and feedback from the field.The field feedback did not provide any information like device serial /lot number, size, and details of the procedure (e.G.Technical difficulties, used sheath, etc).The pictures only showed the leading end of what appears to be two gore® excluder® aaa endoprosthesis contralateral leg device delivery catheters.The distal olive of one of the catheters appeared to have separated from the polyimide guidewire lumen.The pictures did not show any apparent issue with the other gore® excluder® aaa endoprosthesis contralateral leg device delivery catheters.The findings from the evaluation are consistent with the physician¿s observation that the tip of a delivery catheter (distal olive) has separated from the delivery catheter.However, the physician¿s observation that the device (s) was viabahn and the distal olive was separated from the catheter inside of the introducer sheath during the removal of the introducer sheath could not be confirmed without the physical device to evaluate.The likely cause for the reported catheter distal olive separation could not be determined with the currently available information.The evaluation of the reported event appears consistent with the leading olive separation; however, it is impossible to determine if there was a tensile failure of the bond or no bond because the delivery catheter and the separated distal olive were not physically available for evaluation.A capa was initiated on 4/09/2019 to address leading olive separation.It was reported that this device was manufactured before january 2016, therefore the findings of this investigation do not impact the conclusions of this capa.A field safety corrective action was performed and a fsca report was submitted (gore# 3007284313.12102019.001-c) for similar potential failure modes.The current gore® excluder® aaa instructions for use (ifu) states the following: adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: delivery system leading end catheter component retention.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

On january 24, 2023, it was reported to gore that on (b)(6) 2016, the patient was treated for a lesion (not further specified) with a gore® viabahn® endoprosthesis (viabahn device).The endoprosthesis was successfully implanted and the delivery catheter was removed from the patient.It was reported that when the physician removed the introducer sheath from the patient he noticed that the distal tip of the delivery catheter of the viabahn device has separated from the delivery catheter.The distal tip was found at the distal end inside the introducer sheath.Reportedly, the event did not have consequences or an impact to the patient.On february 16, 2023, the physician reported to gore that it could also have been a gore aortic endoprosthesis, and that he cannot remember the case or details of the procedure.The issue was documented that time with a photo that is dated (b)(6) 2016.

• 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 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: 16404981
• MDR Text Key: 310146698
• Report Number: 3013164176-2023-01616
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: No
• 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