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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE TRI-LOBE BALLOON CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number BCL2645J
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aneurysm (1708)
Event Date 04/15/2021
Event Type  Injury  
Manufacturer Narrative

As the device was discarded no product evaluation could be performed. (b)(4).

 
Event Description

The following information was reported to gore: on (b)(6) 2021, this patient underwent endovascular treatment using gore® tri-lobe balloon catheter (tri-lobe) and gore® tag® conformable thoracic stent graft with active control system (ctag ac) for aortic arch aneurysm. Two ctag ac were deployed without issues and touched up using the tri-lobe. Then, it was reported that the blood pressure of the right arm was not confirmed. Angiography revealed retrograde type a aortic dissection (rtad). An ascending and arch aorta replacement was performed. The physician stated as follows; the chest was opened and the entry was confirmed, and rtad was confirmed from the edge of the stent graft. I think the cause might have been the balloon.

 
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Brand NameGORE TRI-LOBE BALLOON CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MEDICAL PHOENIX 1 B/P
32360 n. north valley parkway
phoenix AZ 85085
Manufacturer Contact
samir kulovic
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11824798
MDR Text Key264155791
Report Number3007284313-2021-01429
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK033670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/14/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberBCL2645J
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/09/2020
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: 05/14/2021 Patient Sequence Number: 1
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