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

Model Number PXC161000

Device Problems Therapeutic or Diagnostic Output Failure (3023); No Apparent Adverse Event (3189)

Patient Problems Aneurysm (1708); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2022

Event Type  Injury  

Event Description

On (b)(6) 2012, the patient was implanted with a gore® excluder® aaa endoprosthesis contralateral leg component, for treatment of an aneurysm.As reported, the gore device appeared to have been extended from a non-gore device and was implanted on the right side of the patient.According to medical records there was an aneurysm located down the right iliac artery.On (b)(6) 2017 medical records also indicate follow up examination for a type ii endoleak following a coil embolization in an unspecified location.On (b)(6) 2022, the patient presented with an unspecified degree of aneurysm enlargement.As reported, imaging showed what looked like a type iii endoleak on the left side of the patient.On (b)(6) 2022, the patient underwent a reintervention.As reported, the physician decided to line both the right and left common iliac arteries with gore excluder endoprostheses.As reported, a type ii endoleak was identified originating from the iliolumbar artery.As reported, coil embolization was performed through the internal iliac to address the type ii endoleak.The reintervention procedure went smoothly.The patient tolerated the procedure.As reported, there was no evidence of an endoleak or other issue with the gore® excluder® aaa endoprosthesis contralateral leg component.

Manufacturer Narrative

Medications: lidocaine (pf) 10 mg/ml 1% injection, heparin (pf) 1,000 unit/500 ml in sodium chloride 0.9% (ns) for irrigation solp, fentanyl (pf) injection, midazolam (versed) injection, sodium chloride 0.9% (ns) flush syringe 10 ml, cefazolin (ancef) 2,000 mg in dextrose iso-osmotic ml ivpb (premix), sodium chloride 0.9% (ns) infusion, tamsulosin (flomax) 0.4 mg, diphenhydramine (benadryl) 25 mg capsule, pure probiotic, fa/niacinamide/cupric ox/zn ox (nicotinamide oral), atorvastatin (lipitor) 20 mg tablet, lisinopril (prinivil, zestril) 10 mg tablet, aspirin ec 81 mg tablet, furosemide (lasix) 40 mg tablet, terazosin (hytrin) 10 mg capsule, metoprolol succinate er (toprol-xl) 25 mg tablet, primidone (mysoline) 50 mg tablet, multivitamin capsule, fish oil-omega-3 fatty acids 300-1000 mg capsule, calcium carbonate-vitamin d2 500 mg (1,250mg)-200 unit tablet.Medical history and comorbidities: essential hypertension benign, occasional tremors, premature ventricular contraction, mixed hyperlipidemia, hx prostatectomy, chronic benign neutropenia, coronary atherosclerosis of native coronary artery, postsurgical aortocoronary bypass status-lima to lad and rima to right coronary artery on (b)(6) 2020, (b)(6) 2007, aneurysm of abdominal vessel, endovascular stent graft for abdominal aortic aneurysm, endoleak post evar, edema, aortic incompetence, bpd without obstruction/lower urinary tract symptoms, elevated psa, gross hematuria, hematuria, gastroesophageal reflux disease, cancer: skin basal cell, asthma, covid-19, complication of anesthesia.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.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require additional intraoperative procedure time or intervention include, but are not limited to endoleak and aneurysm enlargement.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.

Event Description

On (b)(6) 2012, the patient was implanted with a gore® excluder® aaa endoprosthesis, pxc161000 (serial (b)(6), for treatment of an aneurysm.As reported, the gore device appeared to have been extended from a non-gore device and was implanted on the right side of the patient.According to medical records there was an aneurysm located down the right iliac artery.On january 12th, 2017 medical records also indicate a subsequent encounter for an endoleak post evar and follow up examination for a type ii endoleak following a coil embolization in an unspecified location.On july 18, 2022, the patient presented with an unspecified degree of aneurysm enlargement.As reported, imaging showed what looked like a type iii endoleak on the left side of the patient.On july 22, 2022, the patient underwent a reintervention.As reported, the physician decided to line both the right and left common iliac arteries with gore excluder endoprostheses.As reported, a type ii endoleak was identified originating from the iliolumbar artery.As reported, coil embolization was performed through the internal iliac to address the type ii endoleak.The reintervention procedure went smoothly.The patient tolerated the procedure.As reported, there was no evidence of endoleak or issue with the gore® excluder® aaa endoprosthesis, pxc161000 (serial (b)(6).

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: description summary updated.G3/g4.Date received by manufacturer was updated to 11-oct-2022 as the manufacturing evaluation was completed on this date.C21, results pending completion of investigation replaced with.D16, conclusion not yet available replaced with d14, no problem detected as there were no issues identified that linked directly back to the gore device.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15235590
• MDR Text Key: 298025973
• Report Number: 3007284313-2022-02078
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132609970
• UDI-Public: 00733132609970
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: PXC161000
• Device Catalogue Number: PXC161000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10/H11
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 93 KG