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

Model Number RLT231412

Device Problems Material Invagination (1336); Material Deformation (2976)

Patient Problem Ischemia (1942)

Event Date 03/27/2023

Event Type  Injury  

Event Description

It was reported to gore that the patient was treated with a gore® excluder® aaa endoprosthesis on (b)(6) 2023.It was stated that a first post-operative cta scan was performed on (b)(6) 2023 and an infolding of the gore® excluder® aaa endoprosthesis (rlt231412 device) has been detected.It was reported that on (b)(6) 2023 a gore® aortic extender endoprosthesis has been successfully implanted to resolve the infolding.The patient tolerated the procedure and was discharged the day after the reintervention.The physician reported, that the patient experienced claudication in the right leg but that he is not aware of any cause of the event.

Manufacturer Narrative

Code b14 and c19: a review of the manufacturing records indicated the device met pre-release specifications.Code b13: additional information to the event and dicom imaging series were requested from the hospital.The images were released and shared with gore for evaluation.The imaging evaluation summary states the following: the aortic diameters on the pre-implant images range from 18 mm ¿ 19 mm.There does not appear to be significant calcification or thrombus.The report of device compression is consistent with the observed crescent-shaped appearance of the device along the lateral arterial wall.There is still flow throughout the implanted devices.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 to gore that the patient underwent endovascular abdominal aortic treatment with a gore® excluder® aaa endoprosthesis on (b)(6) 2023.The first post-operative cta scan performed on (b)(6) 2023, showed infolding of the device.The physician reported that the patient showed claudication in the right leg.On (b)(6) 2023, an aortic extender endoprosthesis has been successfully implanted endovascular to resolve the infolding.The patient tolerated the procedure and was discharged the day after the reintervention.

Manufacturer Narrative

B5: added information to the event description.Cause investigation and conclusion: additional information to the event, anatomical conditions, device information, patient information, and dicom imaging series for evaluation have been requested from the physician.The answers are captured in sections 2 and 3.A review of the manufacturing records indicated the device met pre-release specifications.The device remains implanted in the patient.Therefore a device evaluation could not be performed.Pre- and postoperative computed tomography angiography imaging dicom datasets were provided for evaluation.The imaging evaluation showed the following: the aortic diameters on the pre-implant images range from 18 mm ¿ 19 mm.There does not appear to be significant calcium or thrombus.The report of device compression is consistent with the observed crescent-shaped appearance of the device along the lateral arterial wall.There is still flow throughout the implanted devices.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 claudication.Information available for this event does not identify a manufacturing deficiency or non-conforming product.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.Considering the nature of this event and the results of this investigation, this occurrence did not warrant remedial, corrective or preventative action in addition to no field safety action.The risk management documents for the gore® excluder® aaa endoprosthesis were reviewed.No potential new or different reasonably foreseeable risk related to the device or its use were identified based on this event.The benefit of the product has been assessed against the overall residual risk and determined that the benefit of the product outweighs the risk to the patient.Ongoing risk/benefit assessment and acceptability of residual risk serves to reaffirm risk acceptability based on current performance.No corrective measures are needed as a result of this event.Gore monitors complaints closely to ensure that risks remain within the bounds estimated in the risk management documents.

• 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: kerstin haberlaender ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16617700
• MDR Text Key: 312013687
• Report Number: 3007284313-2023-02406
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622368
• UDI-Public: 00733132622368
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2023
• Device Model Number: RLT231412
• Device Catalogue Number: RLT231412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2020
• 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: 64 YR
• Patient Sex: Male