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

Model Number	PXT281412
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	03/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was investigated as part of a historical gore case (psts event (b)(4)): the field sales associate reported the following: on (b)(6) 2008, the patient underwent treatment of an abdominal aortic aneurysm with a gore® excluder® aaa endoprosthesis trunk-ipsilateral leg component (pxt281412, sn:(b)(4)) and two contralateral leg components (pxc181000, sn:(b)(4) and pxc181200, sn: (b)(4)).On (b)(6) 2013, follow-up imaging identified an unspecified endoleak with aneurysm enlargement of an unknown amount.According to the physician, the endoleak was identified as a type ii endoleak with the source multiple lumbar arteries.On (b)(6) 2013, the patient was implanted with gore® excluder® aaa endoprosthesis contralateral leg component (plc181000, sn:1(b)(4)).Medical records indicate that in 2013 a ct was performed and the maximum aneurysm sac measured 7.4 x 6.6cms.This report/case/investigation was opened to for the following: on (b)(6) 2016, the patient was implanted with a gore® excluder® aaa endoprosthesis aortic extender.Medical records indicate that on (b)(6) 2016 a ct was performed and the maximum aneurysm sac measured 8.8 x 7.2cms.
Additional Manufacturer Narrative
Past medical history: a-fib, aaa (abdominal aortic aneurysm), acute but ill-defined cerebrovascular disease, aicd (automatic cardioverter/defibrillator present, aneurysm, aortic valve disorder, arthralgia, cad (coronary artery disease) severe multi vessel, cataract, cervicalgia, chronic systolic (congestive) heart failure, copd (chronic obstructive pulmonary disease), gastroesophogeal reflux disease with hiatal hernia, gerd with apnea, htn (hypertension), hx of cabg x 4, hypercholesteraemia, ischemic cardiomyopathy, peripheral neuropathy, peripheral vascular disease, prostate troubles, shortness of breath.Past surgical history: sinus surgery, coronary artery bypass graft (l-lad, s-d1, s-pda/om), pacemaker insertion, colonoscopy, upper gastrointestinal endoscopy, cardiac defibrillator placement, pacemaker insertion, abdominal aortic aneurysm repair (endovascular), cataract removal with implant, cervical spine surgery, coronary angioplasty with stent placement, foot surgery, tonsillectomy medications: sodium chloride 0.9%, 10ml, intravenous, once social history: former smoker, no allergies.Communication/interviews- additional information in regard to the event of the case was requested.The provided additional information is captured in the event description.Device not accessible for testing: the medical device remains implanted and was therefore not available for return and evaluation.Results pending completion of investigation: manufacturing evaluation results will be provided once they are completed in full.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
H6.Code c19, no device problem found: a review of manufacturing records verified that the lot involved in this event met all pre-release specifications.B5.Updated the description summary with additional information as received from the field.G3 / g4.Date received by manufacturer updated to 29-nov-2022, as production record review was completed in full on this date.
Event or Problem Description
The following was investigated as part of a historical gore case ((b)(4)): the field sales associate reported the following: on (b)(6) 2008, the patient underwent treatment of an abdominal aortic aneurysm with a gore® excluder® aaa endoprosthesis trunk-ipsilateral leg component (pxt281412, sn:(b)(6)) and two contralateral leg components (pxc181000, sn:(b)(6) and pxc181200, sn: (b)(6)).On (b)(6) 2013, follow-up imaging identified an unspecified endoleak with aneurysm enlargement of an unknown amount.According to the physician, the endoleak was identified as a type ii endoleak with the source multiple lumbar arteries.On (b)(6) 2013, the patient was implanted with gore® excluder® aaa endoprosthesis contralateral leg component (plc181000, sn:(b)(6)).Medical records indicate that in 2013 a ct was performed and the maximum aneurysm sac measured 7.4 x 6.6cms.This report/case/investigation was opened to for the following: on (b)(6) 2016, the patient was implanted with a gore® excluder® aaa endoprosthesis aortic extender.Medical records indicate that on (b)(6) 2016 a ct was performed and the maximum aneurysm sac measured 8.8 x 7.2cms.Medical records identified in-flow to the aneurysm from a lumbar artery.

• 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 WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15786110
• Report Number: 2017233-2022-03477
• Device Sequence Number: 20616394
• Product Code: MIH
• UDI-Device Identifier: 00733132610297
• UDI-Public: 00733132610297
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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: 11/30/2010
• Device Model Number: PXT281412
• Device Catalogue Number: PXT281412
• 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: 10/18/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/13/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2007
• 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; Other
• Patient Age: 79 YR
• Patient Sex: Male