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

Catalog Number BCM1634J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Aortic Dissection (2491)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

Results pending completion of manufacturing evaluation.

Event Description

On (b)(6) 2018, the patient was implanted with two conformable gore® tag® thoracic endoprostheses to treat a thoracic aortic aneurysm.After both endoprostheses were placed, post-implant ballooning was performed using a gore® tri-lobe balloon catheter (bcm1634j/17594551).A procedural angiograph reportedly revealed a dissection at the proximal end of the most proximal gore® tag® device.According to the report, ballooning of the proximal device likely contributed the dissection, which extended to the left subclavian artery.The physician stated that he expected the patient¿s blood vessel would be ¿weak¿.The patient¿s blood pressure was reportedly stable, and procedural angiography did not show any interruption of blood flow to the arch branch vessels.The physician expects the dissection will be thrombosed, and he will continue to monitor the patient.The procedure was completed without any further reported complications, and the patient tolerated the procedure.

Manufacturer Narrative

Code 213 ¿ a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Code 22 ¿ 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 trauma to the vessel wall, including spasm, dissection, perforation, or rupture.

• Brand Name: AORTIC TRI-LOBE BALLOON CATHETER (MODIFIED)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7770480
• MDR Text Key: 116697528
• Report Number: 3007284313-2018-00221
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K081799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2020
• Device Catalogue Number: BCM1634J
• Device Lot Number: 17594551
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR