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

Model Number PLC271000

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Aneurysm (1708); Thromboembolism (2654)

Event Date 10/10/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a patient presented for treatment in the common iliac artery.As reported, an excluder® conformable aaa endoprosthesis with active control system, a gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprostheses (ibe) were utilized, in addition to a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).Post operative scans and fluoroscopy assessments showed a vbx device dislodged and stuck between the proximal ibe device and the aneurysmal sac, potentially causing a type iii endoleak.According to the physician, a type ii endoleak from the lumber arteries and/or the vbx lodged at the proximal iliac branch endoprosthesis caused the problem.The excluder® conformable aaa endoprosthesis with active control system was implanted as intended.The physician mentioned that the aneurysm size was not changed.The patient is doing great.On (b)(6) 2022 was reported that a reintervention procedure is scheduled for (b)(6) 2022.

Manufacturer Narrative

A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.Additional information was requested but was not available.The device remains implanted and is not available for investigation.On (b)(6) 2022, the imaging evaluation was completed.Per imaging evaluation, given the abnormalities of the deployed devices the evaluation can not conclude a type ii or type iii endoleak.According to the goreâ® excluderâ® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to endoleak and occlusion of device or native vessel.Additional considerations for patient selection include but are not limited to patientâ¿¿s anatomical suitability for endovascular repair.Please note that the medwatch reports were provided separately to fda for goreâ® excluderâ® iliac branch endoprostheses (ibe) and a goreâ® viabahnâ® vbx balloon expandable endoprosthesis.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

B5: the event description was updated for reintervention.The information was provided on november 27, 2022.Section d: the device information was added.H6: code c19- a review of the manufacturing records for the device verified the lot met all pre-release specifications.The device remains implanted and is not available for investigation.Per imaging evaluation, given the abnormalities of the deployed devices the evaluation can not conclude a type ii or type iii endoleak.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to endoleak and occlusion of device or native vessel.Users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Successful exclusion of the aneurysm(s) may be affected by significant thrombus at the distal iliac artery interfaces.Irregular plaque may compromise the fixation and sealing of the implantation sites.

Event Description

On (b)(6) 2022, a reintervention was performed.The physician extended the device to the right external iliac artery.The patient tolerated the procedure.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15809152
• MDR Text Key: 303799225
• Report Number: 3013164176-2022-01543
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

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 Model Number: PLC271000
• Device Catalogue Number: PLC271000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 11/27/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male