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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problem Cardiac Perforation (2513)
Event Date 03/08/2017
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 eleven years and six months of post deployment, computed tomography of the abdomen and pelvis revealed the filter was in the infra-renal inferior vena cava. The tip of the filter was positioned at the level of the right pedicle of l2. The superior aspect of the filter was 10 mm distal to the right renal vein. One of the filter struts appears broken and along the right anterior lateral inferior vena cava wall superior to the filter at the 10 o'clock position. The distal aspect of the other struts had perforated the inferior vena cava. One of the struts was within the third portion of the duodenum. Fractured, embolized arm of filter in superior right ventricle of heart at the origin of the main pulmonary artery. Fractured arm of filter adjacent to and slightly superior to the tip of the filter along the right lateral wall of the inferior vena cava. Four arms attached to filter. Six legs attached to filter. 2 o¿clock arm with grade 3 penetration of the inferior vena cava into the third portion of the duodenum. 5 o¿clock leg with grade 3 penetration of the inferior vena cava into the anterior third vertebral body. All other legs and arms with grade 2 penetration of the inferior vena cava. No significant tilt. Therefore, the investigation is confirmed for filter limb detachment and perforation of the inferior vena cava (ivc). 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.

 
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 struts detached and perforated the wall of the inferior vena cava into the third portion of the duodenum and another strut penetrated into the anterior third vertebral body. The device has not been removed and there were no reported attempts made to retrieve the filter. The detached strut embolized in superior right ventricle of the heart at the origin of the main pulmonary artery. The current status of the patient is unknown.

 
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Brand NameRECOVERY FILTER 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 Key12022754
MDR Text Key257447066
Report Number2020394-2021-80514
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031328
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 06/17/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/18/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF048F
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 Received06/08/2021
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: 06/18/2021 Patient Sequence Number: 1
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