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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI JUGULAR SYSTEM VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. DENALI JUGULAR SYSTEM VENA CAVA FILTER Back to Search Results
Model Number DL900J
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Blood Loss (2597)
Event Date 01/25/2019
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately four years post filter deployment, patient presented with flank pain. Subsequent, ct revealed some of the filter struts penetrated through the wall of the ivc into the pericaval/mesenteric fat and the filter tilted to the left and anterior with its proximal cone lying on the wall of the ivc possibly embedded in the ivc. Therefore, the investigation is confirmed for filter tilt and perforation of the ivc. Based upon the available information, the definitive root cause is unknown. Labeling review: a review of product labeling documents (e. G. Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate. (expiry date: 04/2018).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient for familial coagulopathy with recent gi bleed. At some time, post filter deployment, it was alleged that the filter tilted and struts perforated into organs. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient experienced pain and bleeding which is related to the filter; however, the current status of the patient is unknown.

 
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Brand NameDENALI JUGULAR SYSTEM
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9804618
MDR Text Key182615890
Report Number2020394-2020-01342
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 03/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDL900J
Device Catalogue NumberDL900J
Device LOT NumberGFZC3718
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/15/2015
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: 03/09/2020 Patient Sequence Number: 1
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