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

Model Number	PLC141200
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient comorbidities: hypertension (htn), hyperlipidemia (hld), chronic low back pain, spinal stenosis, history of prostate cancer.Medications: ciclopirox external solution 8 %, sulfamethoxazole-trimethoprim oral tablet 800-160 mg, ketoconazole external cream 2 %, meloxicam oral tablet 15 mg, carvedilol oral tablet 12.5 mg, atorvastatin calcium oral tablet 20 mg, venlafaxine hcl er oral capsule extended release 24 hour 150 mg, amlodipine besylate oral tablet 5 mg, losartan potassium oral tablet 100 mg,and fluticasone propionate nasal suspension 50 mcg/act.Allergies: none indicated.Past medical and surgical: the patient has a past medical history of hypertension, cancer prostate cancer, hyperlipidemia, depression, cardiovascular, disease aaa.Other past medical history includes aaa, spinal stenosis.Hernia repair, aaa repair, knee surgery, prostatectomy, former smoker.
Event or Problem Description
On (b)(6) 2019 the patient was implanted with the following gore® excluder® aaa endoprostheses for endovascular aneurysm repair/treatment of an abdominal aortic aneurysm.Rlt231414 (gore lot/sn: (b)(4)) plc141200 (gore lot/sn: (b)(4)) as reported by the physician for history of the presented illness, the post-procedure ultrasound surveillance suggested continued residual aneurysm sac expansion and ct angiography suggested an endoleak was present.Attempted endoleak repair by interventional radiology conducted in (b)(6) 2022 suggested a type i or type iii endoleak.The aneurysm sac remained asymptomatic.On march 17th, 2022 the type iii endoleak was confirmed between the overlap of the gore® excluder® aaa trunk ipsilateral c3 and contralateral leg endoprostheses.As reported, it is unknown if the cause of the endoleak is due to incorrect placement of the contralateral limb resulting in insufficient overlap, or due to endoprosthesis migration.On march 17th, 2022 reintervention was conducted.The procedure consisted of relining the existing components at the device overlap with a plc141000.Angiography was performed following the procedure and confirmed that there was no remaining endoleak.As reported, there were no procedure related complications and the patient is doing well.No images are available for evaluation.
Additional Manufacturer Narrative
H6: replaced code 4112, analysis of data provided by user/third party with code 3331, analysis of production records.No outside records provided.Code 4112 was selected in error.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.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13841311
• Report Number: 3013164176-2022-01337
• Device Sequence Number: 11727004
• Product Code: MIH
• UDI-Device Identifier: 00733132618675
• UDI-Public: 00733132618675
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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
• Device Expiration Date: 04/01/2022
• Device Model Number: PLC141200
• Device Catalogue Number: PLC141200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male