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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 12/11/2013
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. Post filter deployment, computed tomography of abdomen and pelvis was performed which revealed there was a birds nest type of inferior vena cava filter with its proximal tip roughly 5mm inferior to the left renal vein, the distal prongs do appear to extend minimally beyond the wall of the inferior vena cava but not into adjacent organs. One year and one month later, computed tomography of abdomen was performed which revealed there was an infrarenal inferior vena cava filter, which appears to represent a simon nitinol filter. The top of the filter was below the lowest renal vein by 4. 8cm. There was no significant filter tilting. There was a right anterolateral filter leg which is outside of the vena cava wall with 2. 5mm of perforation. There was a right posterolateral filter leg which was perforated beyond the inferior vena cava filter wall up to 5mm. Right posterior filter leg was perforated beyond the inferior vena cava wall to 5mm and in the right anterolateral paravertebral space. Left posterior leg was perforated beyond the inferior vena cava wall by 2mm and in the ventral paravertebral space. No definite filter leg fracture or bending. 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. At some time post filter deployment, it was alleged that the filter struts perforated into organs and the patient reportedly experienced abdominal pain. 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 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 Key12065072
MDR Text Key258303741
Report Number2020394-2021-80527
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 06/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2021
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 Received06/07/2021
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: 06/25/2021 Patient Sequence Number: 1
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