MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TRI-LOBE BALLOON CATHETER (MODIFIED); CATHETER, PERCUTANEOUS

Catalog Number BCL2645J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Aortic Dissection (2491)

Event Date 09/15/2018

Event Type  Death  

Manufacturer Narrative

A review of the manufacturing records for the gore® tri-lobe balloon catheter could not be performed as device lot/serial number is not available.Per the gore® tri-lobe balloon catheter instructions for use, adverse events which may require intervention include, but are not limited to trauma to the vessel wall, including spasm, dissection, perforation or rupture, and death.

Event Description

On (b)(6) 2018, the patient underwent treatment of a ruptured acute stanford type b aortic dissection with two conformable gore® tag® thoracic endoprostheses.The primary entry tear was located approximately 3 cm distal to the left subclavian artery.The distal endoprosthesis was implanted covering the re-entry tear.The proximal endoprosthesis was implanted just distal to the left common carotid artery, intentionally covering the left subclavian artery.Post-implant ballooning was performed on the proximal end of the stent-graft system with a gore® tri-lobe balloon catheter (bcl2645j/lot unknown; volume of balloon inflation is unknown).After a final procedural angiograph was performed, the patient reportedly went into hemorrhagic shock as the incision was being closed.Angiography was performed again, and a retrograde type a dissection was reportedly identified in the ascending aorta.Bleeding in the thoracic cavity due to a perforation of the ascending aorta was also reported.The physician was not able to render any treatment for the dissection and perforation.The procedure was concluded and patient was transferred to the intensive care unit with percutaneous cardiopulmonary support.The patient reportedly expired shortly afterward.

• Brand Name: AORTIC TRI-LOBE BALLOON CATHETER (MODIFIED)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: damon jackson ; 1500 n. 4th street; 9285263030
• MDR Report Key: 7948514
• MDR Text Key: 123128007
• Report Number: 3007284313-2018-00284
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081799
• 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: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BCL2645J
• 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
• 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): Death; Other
• Patient Age: 80 YR