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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
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Death (1802)
Event Date 12/09/2020
Event Type  Death  
Event Description

On (b)(6) 2020, this patient presented with a ruptured descending aortic aneurysm with back pain and underwent emergency endovascular treatment using two gore(r) tag(r) conformable thoracic stent graft (ctag) and a gore(r) tri-lobe balloon catheter (tri-lobe). The first ctag ((b)(4) was deployed at the origin of the left subclavian artery. A suspected distal type i endoleak was observed. Ballooning was performed using the tri-lobe balloon catheter,(b)(6) then a leak was observed at proximal descending aorta, and an aortic rupture was suspected. A second ctag ((b)(4)) was deployed at the origin of the left common carotid artery. Both leaks slightly remained. The physician decided to monitor the patient. The patient tolerated the procedure. On the same day, after returning to intensive care unit, the patient complained of pain again. Computed tomography revealed bleeding and a drop of blood pressure was also observed. The patient underwent a reintervention whereby an additional ctag was deployed in the ascending aorta using chimney technique. Two gore(r) viabahn(r) endoprosthesis with heparin bioactive surface (viabahn) were deployed in the brachiocephalic artery and another two viabahn were deployed in the left common carotid artery as chimney devices. On (b)(6) 2020, early morning, the patient expired. It was reported that the possible cause of death was the rupture of the proximal descending aorta by the ballooning.

 
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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
douglas rhodes
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11117685
MDR Text Key225101294
Report Number3007284313-2021-01220
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
Reporter Occupation
Type of Report Initial
Report Date 01/05/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/05/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received12/10/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 01/05/2021 Patient Sequence Number: 1
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