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

Catalog Number RLT231414

Device Problem Compatibility Problem (2960)

Patient Problem Aneurysm (1708)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: patient medications include but are not limited to: norvasc, metaproterenol, atacand.

Event Description

On (b)(6) 2018, this patient underwent endovascular treatment for a ruptured abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2018, the patient underwent treatment for a proximal type i endoleak and enlargement of the aneurysm.A gore® excluder® aortic extender component was placed proximally and the endoleak was resolved.The endoleak was thought to have been caused by possible migration of the main body of the trunk which sat approximately 12mm distal to the lowest renal artery, however this was unable to be confirmed as post implant imaging of the initial procedure was not available.The amount of enlargement was unknown but the aneurysm was reported to measure 1cm at the time of reintervention.The patient tolerated the procedure.

• 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: laura crawford ; 1500 n. 4th street; 9285263030
• MDR Report Key: 7993326
• MDR Text Key: 124659265
• Report Number: 3007284313-2018-00297
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622375
• UDI-Public: 00733132622375
• 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: 10/18/2018

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: 02/04/2021
• Device Catalogue Number: RLT231414
• Device Lot Number: 17740935
• 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: 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2018
• 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; Other; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 37