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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - JUGULAR VENA CAVA FILTER Back to Search Results
Catalog Number EC500J
Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001); Migration (4003)
Patient Problems Chest Pain (1776); Thrombosis/Thrombus (4440)
Event Date 03/03/2016
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately four years and eleven months of post deployment, computerized tomography-abdomen/pelvis with contrast linear radiopaque density projecting over right upper lung represents a fractured tine from inferior vena cava filter. Thoracic spine x-ray showed a likely fractured piece of inferior vena cava filter in the right lung. Therefore, the investigation is confirmed for filter limb detachment. However, the investigation is inconclusive for filter migration, perforation of inferior vena cava (ivc) and thrombosis. The definitive root cause could not be determined based upon available information. Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate. (expiry date: 11/2013).

 
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 to cephalad, struts detached and perforated. The device has not been removed and there were no reported attempts made to retrieve the filter. The detached struts retained in right lung and the patient experienced chest pain and was diagnosed with thrombosis above the filter; however, the current status of the patient is unknown.

 
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Brand NameECLIPSE FILTER SYSTEM - JUGULAR
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury 12804
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12119640
MDR Text Key260018965
Report Number2020394-2021-01285
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093659
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 06/10/2021
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 Catalogue NumberEC500J
Device LOT NumberGFUJ2242
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
ARIXTRA, IMODIUM, CEFEPIME; BROMFENAC, DICLOFENAC SODIUM, FLUTICASONE; CLINDAMYCIN, ZOSYN, DIFLUCAN; DIPHENHYDRAMINE, NITROGLYCERIN, PANTOPRAZOLE; FUROSEMIDE, LORAZEPAM, MOXIFLOXACIN; PIPERACILLIN-TAZOBACTAM AND CISPLATIN; PROCHLORPERAZINE, PROZAC, CLONAZEPAM; SIMVASTATIN, NEXIUM, DEXAMETHASONE; TRIAMCINOLONE, TOPOTECAN, TAXOL; VANCOMYCIN, ACETAMINOPHEN, ZOFRAN; ZOLPIDEM ONDANSETRON, TRAMADOL,
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