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

Model Number	PLL161407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device): on (b)(6) 2020, the patient was implanted with a gore® contralateral leg endoprostheses, and a gore® viabahn® vbx balloon expandable endoprostheses with the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device).The patient was being treated for an aortic aneurysm involving the visceral vessel(s).It was reported that on (b)(6) 2020, images revealed a type ic endoleak.The type ic endoleak identified on 1 month duplex us and cta scan.Patient scheduled for reintervention surgery with dr.(b)(6) to treat the type ic endoleak.
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: plc201400/ 21428790 udi (b)(4).Patient medications: heparin, clopidogrel and aspirin.
Additional Manufacturer Narrative
Correction additional information determined which device had the adverse event reported (type ic endoleak) on it.The (gore® viabahn® vbx balloon expandable endoprosthesis) has the allegation of deficiency.The medwatch (report # 2017233-2022-03048).The gore® excluder® aaa endoprosthesis pll161407 lot # 21362777 and the plc201400 lot # 21428790 has no product problem or deficiency caused or contributed to an adverse event/incident for the patient.The medwatch (report # 3013164176-2022-01415) will be retracted.

• 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: 14795226
• Report Number: 3013164176-2022-01415
• Device Sequence Number: 20096183
• Product Code: MIH
• UDI-Device Identifier: 00733132618767
• UDI-Public: 00733132618767
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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: 11/19/2022
• Device Model Number: PLL161407
• Device Catalogue Number: PLL161407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG