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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. SIMON NITINOL FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Model Number 2120F
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 05/24/2019
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 six years and eleven months of post deployment, computed tomography of abdomen was performed which showed filter was present in expected location 2. 7cm below the renal veins. The filter was present centrally in the vein with the superior hook just to left of midline but not abutting the vein wall. No fat stranding or fluid collections surrounding the inferior vena cava which appears normal in caliber. Tines of the inferior vena cava filter extend beyond the wall of the inferior vena cava seen in inferior lateral and inferior medial image. These do not pierce the aorta. No inflammatory changes associated with the large or small bowel. No inflammatory changes or masses in the subcutaneous tissues of the abdomen. Therefore, the investigation is confirmed for perforation of 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 and clotting disorder. At some time post filter deployment, it was alleged that the filter struts perforated the inferior vena cava wall. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient experienced pain in abdomen; however, the current status of the patient is unknown.

 
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Brand NameSIMON NITINOL 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 Key12030902
MDR Text Key257134555
Report Number2020394-2021-80516
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK970099
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 06/21/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2120F
Device Catalogue Number2120F
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: 06/21/2021 Patient Sequence Number: 1
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