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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN FILTER
Device Problem Obstruction of Flow (2423)
Patient Problem Pulmonary Embolism (1498)
Event Date 12/06/2015
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 nine years post filter deployment, patient presented with chest pain and lower extremity pain and was found to have sub-massive bilateral pulmonary embolism along with bilateral femoral acute deep vein thrombosis. Subsequent, computed tomography revealed very limited perfusion of the right lower lobe as well as peripheral wedge-shaped filling defects right upper lobe secondary to known pulmonary emboli. Approximately one year later, computed tomography revealed numerous bilateral filling defects within the pulmonary arteries greatest in the lower lobes and the left lower lobe pulmonary artery appears occluded and were demonstrated that there was flow within the infrarenal vena cava where the filter was present. Above the filter, there was flow noted within the vena cava and no thrombus was observed in that region. Inferior vena cava was occluded below level of the inferior vena cava filter. Echocardiogram done revealed severe pulmonary hypertension and dilated right ventricle and right atrium with mild to moderate pericardial effusion and thrombogenic inferior vena cava filter. Approximately ten days later, imaging revealed inferior vena cava was occluded at level of inferior vena cava filter. Therefore, the investigation is confirmed for occlusion of the ivc filter. Additionally, it can be confirmed that the patient experienced pulmonary embolism 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 deployed successfully, the reason for the filter deployment was not provided. At some time post filter deployment, it was alleged that the filter occluded and the patient was diagnosed with pulmonary embolism. 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 NameVENA CAVA FILTER
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 Key10318627
MDR Text Key200204239
Report Number2020394-2020-05023
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
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 07/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN FILTER
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 Received07/02/2020
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: 07/24/2020 Patient Sequence Number: 1
Treatment
AZATHIOPRINE, MIRALAX, SENNOSIDES, VITAMIN D3; COUMADIN, RIVAROXABAN, LASIX, TORSEMIDE; CYMBALTA, OXYCONTIN, LIDOCAINE, SYNTHROID; DIPHENHYDRAMINE, DOCUSATE, HYDROMORPHONE,; DULERA, HYDROXYZINE, CARBAMAZEPINE, DEXTROSE; HEPARIN, BUMEX, PRAVASTATIN, SINGULAIR, ALBUTEROL; INSULIN ASPART, INSULIN GLARGINE, LORATADINE; LOPRESSOR, SILDENAFIL, LOVENOX, GABAPENTIN; MAGNESIUM OXIDE, MAGNESIUM SULFATE, MYCOPHENOLATE; METFORMIN, SEROQUEL, AMITRIPTYLINE, TEGRETOL; METHOTREXATE, CHOLECALCIFEROL, AMLODIPINE; MICONAZOLE, LISINOPRIL, BECLOMETHASONE, OMEPRAZOLE; NICOTINE, POTASSIUM CHLORIDE, QUETIAPINE; SENNA, SODIUM CHLORIDE, VANCOMYCIN, ROBAXIN
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