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

Catalog Number BCL2645J

Device Problem Use of Device Problem (1670)

Patient Problems Aneurysm (1708); Stroke/CVA (1770)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing record for the device verified the lot met all pre-release specifications.Also were involved tgmr404020j/20968178 and tgu454520j/0294386.The medwatch# 2017233-2019-01169 report was emailed on november 21, 2019 to cover these devices.According to the gore® tri-lobe balloon catheter instructions for use (ifu), adverse events which may require intervention include, but are not limited to: local neurologic damage; thrombosis; stroke; myocardial infarction.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.

Event Description

On (b)(6) 2019, the patient underwent an urgent procedure for a thoracic aortic aneurysm rupture using a gore® tag® conformable thoracic stent graft with active control system (ctag-ac), a conformable gore® tag® thoracic endoprostheses (ctag), a 24fr gore® dryseal flex sheath and a gore® tri-lobe balloon catheter.The patient was in shock when he was transferred to the hospital.Heparin was not used during the procedure since act (activated clotting time) was over 200.The ctag-ac was placed below the left subclavian artery and then the ctag was placed distally.Ballooning was performed to secure the stent grafts.The procedure was completed and the patient tolerated the procedure.Four or five days after the procedure (the exact date is unknown), the patient had difficulty speaking clearly and he felt dizzy.A ct revealed that the patient developed cerebral infarction.The physician decided to take a wait-and-see approach.As of (b)(6) 2019, the patient was still in the hospital.The physician stated thrombus was possibly caused since heparin was not used during the procedure and resulted in the cerebral infarction.It was also reported that the cerebral infarction was possibly caused by thrombus during ballooning.

• 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: nataliya baramzina ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9359401
• MDR Text Key: 175260072
• Report Number: 3007284313-2019-00356
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2021
• Device Catalogue Number: BCL2645J
• Device Lot Number: 18506479
• 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: 08/23/2018
• 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
• Patient Age: 78 YR