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

Catalog Number BCL2645

Device Problem Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); Rupture (2208)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

Medications - acetaminophen, allopurinol, amlodipine, atenolo, centrum, claritin, clonazepam, levothyroxine sodium, losartan potassium, lutein, metformin, pravastatin, vitamin d, and warfarin.(b)(4).

Event Description

On (b)(6) 2016, the patient underwent treatment of a thoracic aortic aneurysm with conformable gore® tag® thoracic endoprostheses.It was reported following the implant of two conformable gore® tag® thoracic endoprostheses, final imaging identified a possible distal type i or type ii endoleak.An additional conformable gore® tag® thoracic endoprostheses was implanted to extend distally to the level of the celiac to treat the endoleak.It was reported final touch up ballooning was performed.However, the endoleak reportedly was still present.It was reported after the follow-up ballooning a rupture of the aorta was identified.The patient's anatomy reportedly did not contribute to the rupture of the aortic wall.It was also reported the balloon was not inflated outside of the graft.A small amount of contrast was identified outside of the aortic wall.However, the amount of blood loss is unknown.It was reported the physician implanted another conformable gore® tag® thoracic endoprosthesis covering the celiac artery to successfully treat the rupture.Final imaging identified the initial endoleak to be a type ii endoleak.The patient tolerated the procedure.

Manufacturer Narrative

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

Event Description

An additional conformable gore tag thoracic endoprostheses (tgu282810/14648565) was implanted to extend distally to the level of the celiac to treat the endoleak.

• 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 WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marcos ayala ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5848840
• MDR Text Key: 51224564
• Report Number: 2017233-2016-00681
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2018
• Device Catalogue Number: BCL2645
• Device Lot Number: 13751259
• 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: 04/08/2015
• 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: 86 YR
• Patient Weight: 56