• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • 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
 

BARD PERIPHERAL VASCULAR, INC. DENALI JUGULAR SYSTEM VENA CAVA FILTER Back to Search Results
Model Number DL900J
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Death (1802)
Event Date 01/17/2016
Event Type  Death  
Manufacturer Narrative
Manufacturing review: a lot history review was performed. This is the only complaint to date for this lot number. Therefore, a device history record (dhr) review is not required. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Post filter final spot image revealed that the filter device was in normal configuration positioned below the lowest renal vein. Subsequently few years post filter deployment, patient expired due to pulmonary embolus and presumed deep venous thrombosis. Later autopsy revealed, bilateral pulmonary emboli. Also, non-occlusive emboli were found in main pulmonary arteries, resolving infarct of lower lobe of the right lung and a filter was in place in inferior vena cava with entrapped embolus. However, the medical records allege no device deficiency. Additionally, it can be confirmed that the patient experienced pe post deployment. However, the relationship to the filter is unknown. 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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient was diagnosed with pulmonary embolism post implant and the patient reportedly expired.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10046480
MDR Text Key190606415
Report Number2020394-2020-03385
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130366
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 05/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model NumberDL900J
Device Catalogue NumberDL900J
Device Lot NumberGFZJ0215
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2020
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: 05/12/2020 Patient Sequence Number: 1
Treatment
CYCLOBENZAPRINE, COUMADIN, PERCOCET AND OXYCODONE
-
-