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

Model Number	PXC231400
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following information on the patient was obtained from provided medical records.Medications: fentanyl, heparin, multi-electrolytes, propofol.Conditions/problem list: coronary artery disease, atrial fibrillation, anemia, decreased circulation, fast heartbeat, high cholesterol/triglycerides, pacemaker, high blood pressure, chronic kidney disease, dyspnea on exertion, overactive thyroid, sick sinus syndrome, dacryostenosis, ectropion, bleeding of the stomach and intestines, postherpetic neuralgia, left upper limb pain, chronic gout.Medical history: arrhythmia, blood circulation collateral, gastroesophageal reflux disease, stasis ulcer, gout, degenerative disk disease, pacemaker, peripheral vascular disease.(b)(4).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 endoprosthesis migration, endoleak, and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2012, the patient was implanted with gore® excluder® aaa endoprostheses including a trunk ipsilateral leg component and two contralateral leg components for treatment of an aortic aneurysm.On (b)(6) 2022, the patient was admitted for pain and underwent a reintervention.As reported, a gore® excluder® aaa endoprosthesis contralateral leg component (b)(4) had dislodged and migrated up into the aneurysm sac (approximately 4cm).As reported, a distal type 1 endoleak was confirmed.As reported, there was an unknown degree of aneurysm enlargement, but not a lot.As reported, the cause was ongoing disease progression.As reported, the reintervention procedure involved additional graft implantation down the right common iliac.Reportedly the patient tolerated the procedure.It was noted that the patient had a longer than average aorta.
Additional Manufacturer Narrative
H6.Code b13, communication/interviews- additional information in regard to the event of the case was requested.The provided additional information is captured in the event description in section b5.H6.Code c20, no findings available, the device was not returned for evaluation.An engineering evaluation was conducted to review the migration and available information.The engineering evaluation indicated the following: 1) no device was returned, and no images were provided.2) without a physical sample or images to evaluate, the physician¿s observation that there was a type i endoleak, approximately four (4) centimeter migration, and unknown degree of aneurysm enlargement, could not be confirmed.3) the likely cause for the reported type i endoleak, approximately four (4) centimeter migration, and unknown degree of aneurysm enlargement could not be determined with the available information.G3 / g4.Date received by manufacturer updated to 04-oct-2022, as engineering evaluation was completed in full on this date.H6.Code 3233, results pending completion of investigation, replaced with findings.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.

• 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 SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14999646
• Report Number: 2017233-2022-03118
• Device Sequence Number: 1776955
• Product Code: MIH
• UDI-Device Identifier: 00733132618293
• UDI-Public: 00733132618293
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 10/05/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: PXC231400
• Device Catalogue Number: PXC231400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2011
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 66 KG