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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM VENA CAVA FILTER Back to Search Results
Model Number DL900F
Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problems Pulmonary Embolism (1498); Thrombus (2101)
Event Date 06/03/2014
Event Type  Injury  
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 review is not required. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Lumber spine radiography was performed, and the inferior vena cava filter was demonstrated with apex at the level of the l2 vertebral body. Lower extremity venous doppler ultrasound was performed and there was development of occlusive thrombus extensively throughout the left lower extremity deep venous system including common femoral vein, sfv and peroneal veins. The previously noted occlusive left popliteal vein deep vein thrombosis was again noted. Computed tomography chest was performed and multiple new pulmonary emboli with a large clot burden was noted. The clot had changed and was larger than seen on prior exam. This presumably represented failure of the inferior vena cava filter. Computed tomography angiography abdomen, pelvis and bilateral lower extremities was performed, there was an infrarenal inferior vena cava filter and suprarenal inferior vena cava thrombus which was at the level of the inflow of the renal veins. Therefore, the investigation is inconclusive for the alleged perforation of the ivc, filter tilt and filter migration. Additionally, it can be confirmed that the patient experienced pe post deployment. However, the relationship to the filter is unknown. Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment. However, the relationship to the filter is unknown. Based on 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: 05/2015).

 
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. At some time post filter deployment, it was alleged that the filter migrated, tilted and struts perforated the vena cava wall and to the mesentery. The device has not been removed and there were no reported attempts made to retrieve the filter. The current status of the patient is unknown.

 
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Brand NameDENALI FEMORAL 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 Key10142425
MDR Text Key194770153
Report Number2020394-2020-03902
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,Followup
Report Date 07/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDL900F
Device Catalogue NumberDL900F
Device LOT NumberGFXD3881
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2020
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: 06/11/2020 Patient Sequence Number: 1
Treatment
COUMADIN, LORTAB
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