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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 Complete Blockage (1094); Difficult to Remove (1528)
Patient Problem Pulmonary Embolism (1498)
Event Date 08/21/2017
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: the device history record review could not be performed as the lot number is unknown. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately one year and nine months of post deployment, computerized tomography-abdomen/pelvis with contrast showed that an inferior vena cava filter was in place. The inferior vena cava below the filter was somewhat enlarged and radio dense, which could reflect thrombosis. Two months later, patient presented with shortness of breath. A computerized tomography-chest w/without contrast examination demonstrated no large central pulmonary embolism however there appears to be a questionable small segmental filling defect centrally in the lingual pulmonary artery branch. Lingular segmental pulmonary artery filling defect/ pulmonary embolism were noted. Attempted inferior vena cava filter retrieval was performed on three months later. Patient presented for follow-up to discuss inferior vena cava filter retrieval with inferior vena cava reconstruction. Access was gained via right internal jugular vein. Needle entering the vein was documented and stored to pacs. An 0. 018 wire was advanced through the needle into the vein. The needle was exchanged for a 5 french transitional catheter. The inner dilator and the 0. 018 wire were removed and a 0. 035 amplatz wire was advanced into the inferior vena cava. The wire could not be advanced past the filter. Wire was exchanged for a stiff angled glidewire. This wire was associated through the inferior vena cava filter through the thrombus into the distal inferior vena cava. Pigtail catheter was advanced over the wire and a venogram was performed. Wire was readvanced through the catheter 2 straightened a pigtail. Catheter was retracted to above the filter and a repeat venogram was performed. Images were reviewed. Inferior venacavogram demonstrated complete occlusion of the inferior vena cava at the level of the filter. Infrarenal inferior vena caval filter remains in place. The inferior vena cava was completely collapsed around the apex of the filter and likely chronically sclerotic in the region. The inferior vena cava above this region likely fills with contrast from collaterals including the right and left renal veins. The inferior vena cava below the level of the filter demonstrated no obvious intraluminal filling defect to suggest residual clot. Therefore, the investigation is confirmed for occlusion of the ivc filter and retrieval difficulties. Additionally, it can be confirmed that the patient experienced pulmonary embolism post deployment. However, the relationship to the filter is unknown. Per medical records, multiple attempts were made to engage the apex of the filter but were unsuccessful due to occlusion and pulmonary embolism. This could have contributed to the retrieval difficulties. However, 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 after an attempted but unsuccessful percutaneous removal procedure. The patient was diagnosed with pulmonary embolism post implant; however, 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 Key12120873
MDR Text Key260017987
Report Number2020394-2021-80535
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 07/06/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2021
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 NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2021
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: 07/06/2021 Patient Sequence Number: 1
Treatment
ATORVASTATIN, HYDRALAZINE, LATANOPROST, MELOXICAM; CETIRIZINE, KEPPRA, MELOXICAM; ESCITALOPRAM, CLONIDINE, LEVETIRACETAM; METOPROLOL, MONTELUKAST, PREDNISONE; NORCO, OXYCODONE-ACETAMINOPHEN; SILDENAFIL, SYMBICORT, TRAZADONE, VITAMIN D3; SINGULAIR, MELATONIN; XARELTO, PRADAXA, ALBUTEROL, ASPIRIN
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