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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES AORTIC TRI-LOBE BALLOON CATHETER (MODIFIED) CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Death (1802)
Event Date 08/30/2018
Event Type  Death  
Manufacturer Narrative

The lot number was not provided. Therefore the udi is not available. The review of the manufacturing paperwork could not be performed as the lot number(s) were not available. The gore® tri-lobe balloon catheter instructions for use state ¿do not inflate the balloons in areas of significant calcified plaque. Balloon rupture and / or vessel damage may occur¿. Additionally the ifu states, adverse events which may require intervention include, but are not limited to: rupture and death.

 
Event Description

On (b)(6) 2018, the patient underwent treatment of a thoracic aortic aneurysm with a medtronic endoprosthesis and gore® tri-lobe balloon catheter. It was reported the device was implanted distal to the left subclavian artery (lsa). Reportedly, deployment of the device was successful as the device landed in its intended location. It was reported the physician inflated a gore® tri-lobe balloon catheter completely within device for post implantation ballooning. It was reported the patient had extreme calcification in the landing zone of the device. It was also reported the aortic neck was short (length unknown). It was reported immediately following the ballooning of the device the patient expired due to a ruptured thoracic aorta. The patient expired due to exsanguination. It was reported the patient¿s anatomy (extremely calcified landing zone and short aortic neck) are suspected to have contributed to the ruptured thoracic aorta.

 
Manufacturer Narrative

Corrected brand name.

 
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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
marcos ayala
1500 n. 4th street
9285263030
MDR Report Key7895684
MDR Text Key120959980
Report Number3007284313-2018-00269
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081799
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 10/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2018
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? No
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/20/2018 Patient Sequence Number: 1
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