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

Model Number	RLT281412
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented with an abdominal aortic aneurysm that was treated with gore® excluder® iliac branch endoprostheses and gore® excluder® aaa endoprostheses on a unknown date.The patient tolerated the initial implant procedure.On an unknown subsequent date, the patient presented with groin pain on a bike ride.On (b)(6) 2023, the physician observed device infolding.The weekend of (b)(6) 2023, the aortic main body and the right iliac contralateral leg were explanted.The gore® excluder® iliac branch endoprostheses on the left remain in situ.Reconstruction was achieved by implanting a bifurcated aortic graft, proximally anastomosed to the infra-renal aortic neck of the aneurysm, right common iliac artery origin and left common femoral artery distally.
Additional Manufacturer Narrative
A1: no specific patient details have been provided.Therefore the gore reference number was used as the patient identifier.D10: concomitant medical products gore® excluder® iliac branch endoprosthesis, catalog ceb231410, (b)(6).Gore® excluder® iliac branch endoprosthesis, catalog hgb161407, (b)(6).Gore® excluder® aaa endoprosthesis, catalog plc271200, (b)(6).Gore® excluder® aaa endoprosthesis, catalog plc271400, (b)(6).H6-code b14 and c19: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.H6-code b13: additional information to procedures, event, anatomical conditions, patient information, and dicom imaging series and the explanted device for evaluation have been requested from the physician.The answers are pending.If additional information is provided, gore will initiate the appropriate investigations.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.
Additional Manufacturer Narrative
B3: updated event description cause investigation and conclusion a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.Additional information to procedures, event, anatomical conditions, patient information, and dicom imaging series and the explanted device for evaluation have been requested from the physician.The explanted devices were not returned to gore for evaluation.Case related imaging has been shared with gore.Four imaging time-points were available for evaluation: pre-implantation cta dated (b)(6) 2022, intra-operative angiogram dated (b)(6) 2023, an ultrasound image dated (b)(6) 2023, and an abdominal x-ray dated (b)(6) 2023.¿ pre-implantation imaging dated (b)(6) 2022 shows: o the proximal neck diameters range from 20.6 mm ¿ 21.5 mm.O tortuous aorta and into the lci with proximal lci diameters being ~15 mm.O the left internal iliac artery length appears to be ~40 mm to the first major branch.Diameters range from ~6.7 mm ¿ 17.3 mm.The liia is aneurysmal with stenotic vessel origin.¿ intra-operative angiogram dated 3/9/2023 shows: o the proximal end of the ibe device appears to be deployed distal to the small proximal lci diameters and tortuous portion of proximal lci.O after deployment of the internal iliac component in the liia, the device appears to be compressed at the location of the stenosed proximal liia origin.Ballooning appears to take place throughout the implanted devices.There appears to be flow throughout the internal component post ballooning.O the proximal end of the excluder® device has a bunched appearance in the projection provided.Final angiogram imaging shows flow throughout the implanted devices and no endoleaks are identified.¿ abdominal x-ray dated (b)(6) 2023 shows: o poor quality image.O the 3 proximal device markers are difficult to discern.Possible compressed proximal end of the device on image provided.Cannot confirm without contrast.¿ no post-implantation cta imaging available for evaluation.Information available for this event does not identify a manufacturing deficiency or non-conforming product.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.¿ genitourinary complications.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.
Event or Problem Description
It was reported that a patient presented with an abdominal aortic aneurysm that was treated with gore® excluder® iliac branch endoprostheses and gore® excluder® aaa endoprostheses on an unknown date.The patient tolerated the initial implant procedure.On (b)(6) 2023, the patient presented with groin pain on a bike ride and presented to the emergency room.The physician observed proximal infolding of the aortic mainbody rlt281412.The device did not appear to be fully open.The weekend of (b)(6) 2023, the aortic main body and the right iliac contralateral leg were explanted.The gore® excluder® iliac branch endoprostheses on the left remain in situ.Reconstruction was achieved with implanting a bifurcated aortic graft, proximally anastomosed to the infra-renal aortic neck of the aneurysm, right common iliac artery origin and left common femoral artery distally.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: 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: 16983386
• Report Number: 3007284313-2023-02516
• Device Sequence Number: 6762817
• Product Code: MIH
• UDI-Device Identifier: 00733132622528
• UDI-Public: 00733132622528
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2025
• Device Model Number: RLT281412
• Device Catalogue Number: RLT281412
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown