MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	PLA280300
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications - acetaminophen (tylenol) 500 mg, allopurinol (zyloprim) 300 mg, aspirin (aspirin ec adult low strength) 81 mg, blood glucose monitoring supply (one touch ultra system kit) w/device kit, clopidogrel (plavix) 75 mg, glucose blood (one touch ultra test) test strip, hydralazine (apresoline) 25 mg, insulin pen needle (bd pen needle nano u/f) 32g x 4mm misc, isosorbide mononitrate (imdur) 30 mg, levemir flextouch 100 units/ml injection pen, losartan (cozaar) 50 mg, metformin (glucophage) 1000 mg, metoprolol succinate (toprol-xl) 25 mg, omega-3 fatty acids (fish oil) 1,000 mg, potassium chloride (k-dur,klor-con) 20 meq, rosuvastatin (crestor) 20 mg, senna-docusate sodium (senokot s) 8.6-50 mg per tablet, sitagliptin (januvia) 100 mg, torsemide (demadex) 20 mg.The review of the manufacturing paperwork verified that the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, improper component placement and renal artery occlusion.
Event or Problem Description
On (b)(6) 2019 the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported that, upon placement of the pla280300 aortic extender component for proximal extension, the device deployed at an angle.Reportedly the angle placed the device higher on the left, subsequently causing partial coverage of the patient's lowest renal artery (left renal).The physician attempted to pull the aortic extender component down using an aortic balloon (q50).The attempt was unsuccessful.The physician placed a 5mmx17mm stent (type unknown) in the patient's left renal artery.After placement of the stent the physician reported that the blood flow to the patient's left renal artery had been completely restored and normalized.The remainder of the procedure was completed with no further reported issues.The patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8880200
• Report Number: 3013164176-2019-00103
• Device Sequence Number: 291149
• Product Code: MIH
• UDI-Device Identifier: 00733132618781
• UDI-Public: 00733132618781
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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: 05/16/2021
• Device Catalogue Number: PLA280300
• Device Lot Number: 18138112
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIST OF MEDICATIONS.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 68