MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® TRI-LOBE BALLOON CATHETER; CATHETER, PERCUTANEOUS

Catalog Number BCL2645J

Device Problem Leak/Splash (1354)

Patient Problems Chest Pain (1776); Hemorrhage/Bleeding (1888); Aortic Dissection (2491)

Event Date 01/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2015, the patient underwent endovascular repair of a distal aortic arch aneurysm using a non-gore endoprosthesis.Intra-procedure imaging revealed a proximal type i endoleak so that the patient was additionally implanted with a conformable gore tag thoracic endoprosthesis and a touch-up ballooning was performed using a gore tri-lobe balloon catheter (bcl2645j/13902769).A final angiography revealed that the endoleak still remained, but the procedure was concluded with a wait-and-watch approach taken to the endoleak.On (b)(6) 2015, a follow-up computed tomography (ct) did not reveal problems to the patient.On (b)(6) 2016, the patient admitted to the hospital with chest pain.A ct revealed a retrograde type a aortic dissection from the proximal end of the ctag device.The ascending aorta and aortic arch were replaced with a surgical graft to treat the retrograde aortic dissection.Reportedly, it was unknown when the retrograde aortic dissection occurred.The proximal edge of the endoprosthesis or touch-up ballooning may have caused the aortic dissection, but the exact cause was unknown.Later, the patient was discharged of the hospital.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Manufacturer Narrative

Review of this file determined there is no allegation against the balloon catheter.Therefore, this report will be retracted.

• Brand Name: GORE® TRI-LOBE BALLOON CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL DEER VALLEY B/P; 24416 n. 19th avenue; phoenix AZ 85085
• Manufacturer Contact: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5521912
• MDR Text Key: 41022152
• Report Number: 3007284313-2016-00041
• 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,Followup,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2018
• Device Catalogue Number: BCL2645J
• Device Lot Number: 13902769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2015
• 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: 84 YR