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

Model Number	PLC231200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The field sales associate (fsa) reported the following: on (b)(6) 2021, 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 (date and modality is unknown), revealed a distal type i endoleak.A reintervention on (b)(6) 2022.The physician placed an iliac branch endoprosthesis on the left side and a ceb231010a & 8lvbx by 79 was used/implanted.The endoleak was resolved.The patient tolerated the procedure.Additional devices implanted and/or related to this event: plc231200/ 23153505 udi 00733132618569.
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: plc231200/ 23153505 udi (b)(4).Patient weight: 98 kg.Patient comorbidities: coronary artery disease, hyper thyroidism, hyperlipidemia, type two diabetes, hypertension and sleep apnea.Patient medications: none.(b)(4).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
Correction h6.
Additional Manufacturer Narrative
Addition b6.
Additional Manufacturer Narrative
Correction additional information determined which device had the adverse event reported (distal type i endoleak) on it.The (gore® excluder® aaa contralateral leg endoprosthesis plc231200 lot # 23153505 ) has the allegation of deficiency.The gore® excluder® aaa trunk-ipsilateral leg endoprosthesis rlt261414 lot # 23153505 has no product problem or deficiency caused or contributed to an adverse event/incident for the patient.
Additional Manufacturer Narrative
H6: conclusion coding has been updated.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15331147
• Report Number: 3013164176-2022-01476
• Device Sequence Number: 12106104
• Product Code: MIH
• UDI-Device Identifier: 00733132618569
• UDI-Public: 00733132618569
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: PLC231200
• Device Catalogue Number: PLC231200
• 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; 08/08/2022; 08/08/2022; 11/11/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/14/2022; 10/30/2022; 10/30/2022; 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 98 KG