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	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
The fsa reported: on (b)(6) 2021, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The patient tolerated the procedure.During the initial implant procedure, the contralateral leg endoprosthesis was overlapped by 3-4cm.It was reported that images (date and modality is unknown), revealed a type iii endoleak (component disconnection) due to device distal migration.There is no aneurysm sac enlargement.On (b)(6) 2021, a reintervention occurred.The physician implanted a contralateral leg endoprosthesis (231400 limb) across the two disconnected parts.The doctors gained access through the disunion and bridged it with a contralateral leg endoprosthesis (231400 limb).The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition h6 impact code.Addition h6 component code.Addition h6: code 213-the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Addition h6: code 4315-cause of endoleak could not be established addition computed tomography images dated (b)(6) 2021, were evaluated by gore imaging services.The imaging evaluation stated there is no overlap between the ipsilateral limb of the main body and the contra-lateral limb used as an ipsi-limb extension.Unable to assess the alleged distal device migration using the available images.There appears to be approximately 12mm from the end of the l contra-limb extension to the l hypogastric artery.The cause of the endoleak could not be established.

• 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: 12586965
• Report Number: 3013164176-2021-01251
• Device Sequence Number: 11063921
• Product Code: MIH
• UDI-Device Identifier: 00733132618569
• UDI-Public: 00733132618569
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 12/15/2021

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: 03/27/2024
• 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): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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: 83 YR
• Patient Sex: Female