• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

W.L. GORE & ASSOCIATES AORTIC TRI-LOBE BALLOON CATHETER (MODIFIED) CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number BCL2645J
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Aneurysm (1708)
Event Date 06/20/2018
Event Type  Injury  
Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications. The gore® tri-lobe balloon catheter instructions for use states that adverse events which may require intervention include, but are not limited to: trauma to the vessel wall, including dissection, perforation or rupture.
 
Event Description
On (b)(6) 2018, the patient underwent surgical de-branching of the left subclavian artery, the left common carotid artery and the innominate artery prior to endovascular repair of a thoracic aortic aneurysm. On (b)(6) 2018, the patient underwent endovascular repair of a thoracic aortic aneurysm. Two conformable gore® tag® thoracic endoprostheses (proximal: tgu454520j/(b)(4), distal: tgu373715j/(b)(4)) were successfully deployed although a bird beak configuration was observed in the proximal part of tgu454520j/(b)(4). The procedure was completed without further treatment since no endoleak and no vessel rupture/dissection was observed. The patient tolerated the procedure. On (b)(6) 2018, a follow-up computed tomography (ct) revealed a retrograde thoracic aortic dissection originating around the proximal end of tgu454520j/(b)(4) device and leading to a coronary artery. An open surgery was performed to treat the dissection. The clinical specialist visited the medical facility on (b)(6) 2018, and following information was provided by the medical facility. Excessive ballooning was performed during the procedure and the tip of the balloon was thought to be positioned outside of the proximal part of conformable gore® tag® thoracic endoprostheses. Therefore, the dissection was caused by the balloon instead of the conformable gore® tag® thoracic endoprostheses, although the dissection was not noticed during the procedure. After the dissection was observed with the follow up ct, the patient was transferred to another medical facility. Therefore, it is unknown what kind of treatment was performed for the dissection. It is also unknown the current patient condition.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAORTIC TRI-LOBE BALLOON CATHETER (MODIFIED)
Type of DeviceCATHETER, 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
rachael chascsa
1500 n. 4th street
9285263030
MDR Report Key7696941
MDR Text Key114276458
Report Number3007284313-2018-00209
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K081799
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2021
Device Catalogue NumberBCL2645J
Device Lot Number17849301
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/17/2018 Patient Sequence Number: 1
-
-