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 Aneurysm (1708); Vascular Dissection (3160)

Event Date 07/16/2018

Event Type  Death  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore tri-lobe balloon catheter instructions for use (ifu), adverse events which may require intervention include but are not limited to: trauma to the vessel wall, including dissection.

Event Description

In (b)(6) 2018, the patient was scheduled to receive treatment of an aortic arch aneurysm.However, the patient refused to have the procedure even though the physician mentioned about the risk of the aneurysm rupture.On (b)(6) 2018, the patient was transferred to the hospital due to his back pain.It was confirmed that the aneurysm had been ruptured.It was determined to perform an urgent tevar with conformable gore tag® thoracic endoprosthesis.Prior to endoprosthesis implant, the left common carotid artery and the left subclavian artery were surgically bypassed.Then the conformable gore tag® thoracic endoprosthesis (tgu454520j/18044685) was placed in the aortic arch.The half of the innominate artery ostium was covered by the endoprosthesis intentionally.It was observed a bird beak in the endoprosthesis and resulted in a severe proximal type i endoleak.There was an evidence of thrombosed dissection that had been previously caused in the ascending aorta.The dissection appeared to be chronic.The endoprosthesis placed in the aortic arch was softly secured using a gore® tri-lobe balloon catheter (bcl2645j/17911587) to resolve the bird beak and the proximal type i endoleak.At that time, blood pressure decreased.It was thought that re-dissection was caused in the ascending aorta.A contralateral leg component was placed in the innominate artery using chimney technique and a tgu454520j/18044684 device was paced in the ascending aorta to treat the dissection.The dissection was resolved and no bleeding was observed.However, the blood pressure did not go up.Cardiac massage was performed but it was not valid.The patient was sent to the intensive care unit.The patient expired when he was transferred to the intensive care unit without further treatment.An autopsy was not performed.Reportedly, the bird beak and the proximal type i endoleak were thought to be caused by the use of smaller endoprosthesis for the target vessel.The adequate sized endoprosthesis was not able to be prepared due to the urgent procedure.It was also reported that the reason why blood pressure decreased was not resolved even after the successful treatment of the dissection.Reportedly, the cardiac tamponade was possibly the cause.

• 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: 7774580
• MDR Text Key: 116856298
• Report Number: 3007284313-2018-00223
• 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,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2021
• Device Catalogue Number: BCL2645J
• Device Lot Number: 17911587
• 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): Death; Hospitalization; Life Threatening
• Patient Age: 85 YR