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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE MOLDING & OCCLUSION BALLOON CATHETER CATHETER, PERCUTANEOUS

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W. L. GORE & ASSOCIATES, INC. GORE MOLDING & OCCLUSION BALLOON CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number MOB37
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aneurysm (1708)
Event Date 07/20/2020
Event Type  Injury  
Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications. The gore® molding and occlusion balloon catheter instructions for use, under adverse events states, trauma to the vessel wall, including dissection.

 
Event Description

The following was reported to gore: on (b)(6) 2020, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprostheses. It was reported that a contralateral leg endoprosthesis was deployed in the left common iliac artery and touch-up ballooning was performed by a gore® molding & occlusion balloon catheter. Then, it was observed a dissection at the distal edge of the contralateral leg endoprosthesis. The stent (epic) was implanted in the left common iliac artery to the left external iliac artery. The blood flow of the left internal iliac artery was decreased due to the stent implantation, but the physician didn't capture it as an issue. It was reported that the diameter of the left common iliac artery at the site of the implantation of the distal end of the contralateral leg endoprosthesis was 11 mm. The root cause of the dissection was reportedly unknown.

 
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Brand NameGORE MOLDING & OCCLUSION 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
rachael chascsa
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key10407210
MDR Text Key202888142
Report Number3007284313-2020-01038
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK172567
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 01/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMOB37
Device Catalogue NumberMOB37
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 Received07/20/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/06/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/14/2020 Patient Sequence Number: 1
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