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

Model Number	PLA320400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient comorbidities: hypertension and pvd.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
On (b)(6) 2019, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that the patient had a possible proximal type i or type ii endoleak (date and modality of images is unknown) and the physician wanted to reintervene.There is aneurysm sac enlargement reported (amount is unknown).The physician determined that it was a proximal type i endoleak and during reintervention placed 12 aptus screws in the area of the proximal neck of the initial graft (pla320400/18785494).In addition, the physician placed a palmaz stent (p4010) in the area as well to treat the endoleak.Upon completion of this intervention, the endoleak was successfully treated and the patient is reported to be doing well.
Additional Manufacturer Narrative
Addition h6: code 213-a review of the manufacturing records for the device verified that the lot met all pre-release specifications.
Additional Manufacturer Narrative
Addition g5.

• Brand Name: GORE EXCLUDERAAA 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
• MDR Report Key: 10691998
• Report Number: 3013164176-2020-01057
• Device Sequence Number: 17120433
• Product Code: MIH
• UDI-Device Identifier: 00733132618804
• UDI-Public: 00733132618804
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2021

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: 11/01/2021
• Device Model Number: PLA320400
• Device Catalogue Number: PLA320400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 10/16/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 12/29/2020; 01/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 88 YR
• Patient Weight: 80