• 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, INC. GORE MOLDING & OCCLUSION BALLOON CATHETER 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, 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 10/19/2020
Event Type  Injury  
Manufacturer Narrative

The gore® molding and occlusion balloon catheter instructions for use, under adverse events states, thrombosis and embolization.

 
Event Description

The following was reported to gore: on october 19, 2020, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprostheses. After all devices were implanted, final angiography revealed that the blood flow of the left renal artery couldn¿t be confirmed. Three gore® viabahn® vbx balloon expandable endoprostheses were implanted in the left renal artery to the aorta. The thrombus was observed in a trunk ipsilateral leg endoprosthesis as well. The blood flow of the left renal artery was able to be confirmed, and the procedure was concluded. The physician stated that the thrombus might have scattered into the renal artery during the touch up ballooning for an aortic extender endoprosthesis because the patient artery from the aortic arch to the infrarenal aortic neck was shaggy. Reportedly the blood flow of the renal artery had no problem before the implantation of the aortic extender endoprosthesis. It was reported the thrombus in the trunk came from the shaggy aorta as well.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10785188
MDR Text Key214582042
Report Number3007284313-2020-01147
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,Followup
Report Date 01/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2020
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 Received10/19/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2020
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: 11/04/2020 Patient Sequence Number: 1
-
-