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

Catalog Number RLT231412

Device Problem Insufficient Information (3190)

Patient Problem Aneurysm (1708)

Event Date 11/28/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: patient medications: tylenol, aspirin, lipitor, colace, milk of magnesia, melatonin, flomax and turmeric root.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to surgical conversion and occlusion of device or native vessel.

Event Description

On (b)(6) 2019, the patient was implanted with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses to treat an abdominal aortic aneurysm and an iliac artery aneurysm.The patient tolerated the procedure.It was reported that on (b)(6) 2019, the patient presented to the emergency department with approximately one hour of numbness and weakness in bilateral lower extremities.Images revealed that the proximal portion of the gore® excluder® aaa endoprosthesis (rlt231412/20285167) had infolded and caused partial blockage of blood flow to the lower extremities.The physician reintervened and explanted the proximal portion of the trunk-ipsilateral leg endoprosthesis and sew in a dacron graft.Post procedure the numbness and weakness was gone and the patient tolerated the reintervention.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: rachael chascsa ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9532108
• MDR Text Key: 185715286
• Report Number: 3007284313-2019-00399
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622368
• UDI-Public: 00733132622368
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2022
• Device Catalogue Number: RLT231412
• Device Lot Number: 20285167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR