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

Catalog Number BCL2645J

Device Problem Insufficient Information (3190)

Patient Problem Stroke/CVA (1770)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified that lot met all pre-release specifications.Per the gore® tri-lobe balloon catheter instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to embolization and stroke.

Event Description

On (b)(6) 2018, the patient was emergently transferred to the hospital due to a suspected impending rupture of thoracic aortic aneurysm.No procedure was performed on this day because the patient was deemed not healthy enough to undergo any operation.On (b)(6) 2018, the patient¿s health was reportedly improved.On this day, he underwent treatment of the suspected impending thoracic aortic aneurysm rupture with a conformable gore® tag® thoracic endoprosthesis.The endoprosthesis was implanted from zone zero of the ascending aorta using a 22fr gore® dryseal sheath with hydrophilic coating.Prior to the procedure, a surgical bypass of the left common carotid and left subclavian arteries was performed.A gore® excluder® contralateral leg component was then implanted into the brachiocephalic artery in a ¿chimney¿ fashion using a 12fr gore® dryseal flex sheath.During the procedure, a type i endoleak was reportedly observed.Additional proximal ballooning was performed using a gore® tri-lobe balloon catheter (bcl2645j/17503872), however, the endoleak was not resolved.The physician coil-embolized a gap (gutter) between the gore® tag® device and the vessel wall, and the endoleak was then slightly diminished.The procedure was concluded without any further reported complications.The patient tolerated the procedure.Immediately after the procedure, a cerebral infarction was reportedly identified.The physician reported that the patient was a high-risk for surgery, and that the cerebral infarction may have been caused by thrombus scattering.The patient¿s current status is unknown.

• 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 PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: damon jackson ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7469448
• MDR Text Key: 106782263
• Report Number: 3007284313-2018-00135
• 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: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2020
• Device Catalogue Number: BCL2645J
• Device Lot Number: 17503872
• 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: 11/30/2017
• 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): Other
• Patient Age: 89 YR