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

Model Number	PLC181400
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021 the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe), gore® viabahn® vbx balloon expandable endoprostheses (vbx), gore® excluder® aaa contralateral leg components, a gore® excluder® iliac branch endoprosthesis, gore® molding & occlusion balloon catheters, gore® tri-lobe balloon catheters, gore® dryseal flex introducer sheaths, and gore® tri lumen catheters in the aaa1701 tambe pivotal study.On the morning of (b)(6) 2021 the patient reported blurred vision (diplopia).The patient was evaluated by the hospital stroke team and an mri of the patient's brain was performed.It was reported that the mri was without evidence of acute stroke.It was reported that the patient's blurred vision resolved itself later on the morning of (b)(6) 2021.There was reportedly no residual.
Additional Manufacturer Narrative
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
H.6.Investigation conclusions code d15 remains unchanged.H.6.Investigation conclusions code d12 added.According to the gore® excluder® aaa endoprosthesis instructions for use, potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, embolization (micro and macro) with transient or permanent ischemia.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #plc141000/ serial #(b)(6)/ udi #(b)(4).Catalog #plc181200/ serial #(b)(6)/ udi #(b)(4).Catalog #plc161400/ serial #(b)(6)/ udi #(b)(4).As the same system of components.Catalog #mob37/ serial #(b)(6)/ udi #(b)(4).Which is captured in manufacturer report #3007284313-2022-01987.Catalog #ceb231410a/ serial #(b)(6)/ udi #(b)(4).Which is captured in manufacturer report #3013164176-2022-01418.Catalog #bxa095902a/ serial #(b)(6)/ udi #(b)(4).Catalog #bxa065902a/ serial #(b)(6)/ udi #(b)(4).Catalog #bxa067902a/ serial #(b)(6)/ udi #(b)(4).Catalog #bxa065902a/ serial #(b)(6)/ udi #(b)(4).Catalog #bxa067902a/ serial #(b)(6)/ udi #(b)(4).Catalog #bxa097902a/ serial #(b)(6)/ udi #(b)(4).Which are captured in manufacturer report #2017233-2022-03049.Catalog #dsf1233/ serial #(b)(6)/ udi #(b)(4).Catalog #dsf2233/ serial #(b)(6)/ udi #(b)(4).Catalog #dsf1245/ serial #(b)(6)/ udi #(b)(4).Which are captured in manufacturer report #3007284313-2022-01988.Catalog #tlc140/ serial #(b)(6)/ udi #(b)(4).Which is captured in manufacturer report #3007284313-2022-01989.Catalog #bcm1634k/ serial #(b)(6)/ udi #(b)(4).Which is captured in manufacturer report #3007284313-2022-01986.B.4.Event description: additional information added.H.6.Investigation findings: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation conclusions: code d15 - this complaint was initiated based on information received from a clinical study database.The information reported in the complaint does not reasonably suggest that a potential device malfunction has occurred.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.Additional information was requested from the field; however, no attributable cause or contributing factors to the adverse event could be identified.Therefore, the cause of the reported adverse event could not be determined with the available information.H.6.Medical device problem code 3190 updated to code a24 h.6.Investigation findings: code 3233 updated to code c19.H.6.Investigation conclusions: code 11 updated to code d15.
Event or Problem Description
The possible cause of the transient ischemic attack is reportedly unknown.It was noted that there was nothing that contributed to the event anatomically.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14795922
• Report Number: 3013164176-2022-01417
• Device Sequence Number: 5057820
• Product Code: MIH
• UDI-Device Identifier: 00733132618699
• UDI-Public: 00733132618699
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2022

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: 02/24/2022
• Device Model Number: PLC181400
• Device Catalogue Number: PLC181400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 12/15/2022; 12/15/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 12/15/2022; 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLOPIDOGREL 75MG.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White