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

Catalog Number RLT231218J

Device Problem Human-Device Interface Problem (2949)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Per the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention include, but are not limited to endoprosthesis component occlusion.

Event Description

On (b)(6) 2018, the patient underwent an endovascular repair of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis (rlt231218j/18406035).According to the report, there was difficulty in cannulating the contralateral gate of the trunk-ipsilateral leg component.The trunk-ipsilateral leg component was reportedly rotated, and the cannulation was performed as intended.The procedure was completed without further reported issues, and the patient tolerated the procedure.On (b)(6) 2018, the patient¿s ankle-brachial-index (abi) was decreased to 0.5.Follow-up examination reportedly revealed that the ipsilateral leg of the trunk-ipsilateral leg component was twisted.The physician thought the twist may have been caused when the trunk-ipsilateral leg component was rotated during the initial procedure.On (b)(6) 2018, a re-intervention procedure was performed.An intravascular ultrasound reportedly showed that the ipsilateral leg of the trunk-ipsilateral leg component was extremely stenosed.According to the report, the stenosis of the ipsilateral leg was seen approximately 1cm below the contralateral gate.When ballooning was performed, the patient¿s abi increased only temporarily.It was reported that the stenosed/twisted aspect of the device had moved upward slightly after ballooning, but the stenosis was not resolved.A bare metal stent was then placed in the ipsilateral leg.The stenosis was resolved, and the numerical value of abi increased to 0.91.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: damon jackson ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8070730
• MDR Text Key: 127141241
• Report Number: 3007284313-2018-00320
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2021
• Device Catalogue Number: RLT231218J
• Device Lot Number: 18406035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2018
• 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; Required Intervention
• Patient Age: 76 YR