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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 Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2016
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 02/2015).
 
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 and pulmonary embolism.Approximately four years and four months post filter deployment, computed tomography (ct) revealed that the filter tilted and struts perforated.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.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, four years and four months of post-deployment, computed tomography of abdomen and pelvis without contrast showed that the bard inferior vena cava filter was positioned below the renal veins.Some of the filter struts have penetrated through the wall of the inferior vena cava into the pericaval or mesenteric fat.The filter was tilted to the right with its proximal cone lay on the wall of the inferior vena cava possibly embedded in it.Around, two years and ten months later, computed tomography of abdomen was revealed that an inferior vena cava filter was noted with the filter tip 2.9 cm below the level of the renal veins.There was 25 degrees of angulation/tilt with respect to the long axis of the inferior vena cava and the apex of the filter touched the right lateral wall of the inferior vena cava.One of the struts of the filter perforated the posterior inferior vena cava and contacted the anterior surface of the l3 vertebral body.Possibly 3 other struts perforated the inferior vena cava wall and were within the right aspect of the aortic wall.Therefore, the investigation is confirmed for the perforation of the inferior vena cava(ivc) and filter tilt.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4(expiry date: 02/2015),g3,h6(method).H11: h6(result and conclusion).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
 
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 and pulmonary embolism.Approximately four years and four months post filter deployment, computed tomography (ct) revealed that the filter tilted and struts perforated.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 Name
ECLIPSE FILTER SYSTEM - JUGULAR
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key12172323
MDR Text Key261657241
Report Number2020394-2021-01336
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K093659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEC500J
Device Lot NumberGFWA4246
Was Device Available for Evaluation? No
Date Manufacturer Received07/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATENOLOL, AND COUMADIN; ATENOLOL, AND COUMADIN; METFORMIN, PRAVASTATIN; METFORMIN, PRAVASTATIN; ATENOLOL, AND COUMADIN; METFORMIN, PRAVASTATIN
Patient Outcome(s) Other;
Patient Age60 YR
Patient Weight115
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