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

Model Number	PLC201400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: plc201000/ 15295191 udi 00733132618590.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include but are not limited to endoleak.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 or Problem Description
The field sales associate (fsa) reported the following: on (b)(6) 2017, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure.It was reported that images (computed tomography dated july 14, 2022), revealed bilateral distal type i endoleak and a type ii endoleak.Contralateral leg endoprostheses are implanted on the distal ends of the gore® excluder® aaa endoprostheses featuring c3® delivery system.The event is ongoing.It is unknown if there is aneurysm sac enlargement, a reintervention is planned.
Additional Manufacturer Narrative
Addition patient¿s comorbidities: coronary artery disease, hyperthyroidism, hyperlipidemia, type two diabetes, hypertension and sleep apnea.Addition patient weight: 98kg.Addition it was reported that on (b)(6) 2022, there was a reintervention.The physician implanted a gore® iliac branch endoprosthesis (ceb231010a) and a gore® viabahn® vbx balloon expandable endoprosthesis in the iliac artery.The endoleak was resolved and the patient tolerated the procedure.The amount of aneurysm sac enlargement is unknown.Addition images were sent to gore imaging services for evaluation.Per the evaluation one time-point available for evaluation, post-implantation computed tomography (cta) dated (b)(6) 2022.Lack of device apposition in the distal limb extending into the right common iliac artery (rci).Contrast is visualized pooling outside the right device limb and communicating with the aneurysm sac, confirming a type ib endoleak.Rci diameters appear to range from 21.3mm ¿ 24.3mm.(plc201400 and plc201000 treatment diameters 16.5mm ¿ 18.5mm) there appears to be ~3mm of seal in the left common iliac artery (lci).Lci diameters range from 17.6mm (distal) ¿ 22.7mm.Maximum aaa diameter on (b)(6) 2022, appears to be 67.1mm x 69.6mm.Cannot confirm aneurysm growth with one time-point.There appears to be increased pooling of contrast in the delayed series images suggesting the presence of type ii endoleak(s).There is a set of lumbar arteries with bright contrast communicating with pooling contrast in the sac, thereby, suggesting a type ii endoleak involving lumbar arteries.Cannot confirm ante grade or retrograde flow with available imaging.H3-no devices were returned to gore for evaluation, devices remain implanted.

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15351093
• Report Number: 2953161-2022-01146
• Device Sequence Number: 6049627
• Product Code: MIH
• UDI-Device Identifier: 00733132618552
• UDI-Public: 00733132618552
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: PLC201400
• Device Catalogue Number: PLC201400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 02/28/2023
• Date Device Manufactured: 12/23/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female