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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pulmonary Embolism (1498)
Event Date 06/29/2018
Event Type  Injury  
Manufacturer Narrative
A 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 twelve years and five months of post deployment, a computed tomography angiogram of chest was performed which showed that positive for several small sub segmental acute pulmonary emboli in the left upper lobe. Three days later, a computed tomography angiogram of chest was performed which showed positive for several small sub segmental acute pulmonary emboli in the left upper lobe. Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter. Additionally, it can be confirmed that the patient experienced pe post deployment. However, the relationship to the filter is unknown. 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 unknown reason. Approximately twelve years and five months later post filter deployment, the patient was diagnosed with pulmonary embolism. 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 Key11989733
MDR Text Key255927569
Report Number2020394-2021-80506
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970099
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 06/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received06/03/2021
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: 06/14/2021 Patient Sequence Number: 1
Treatment
ASPIRIN, INSULIN AND METFORMIN
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