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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 Abdominal Pain (1685)
Event Date 12/25/2017
Event Type  Injury  
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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with bilateral lower extremity lymphedema. Approximately eleven years and seven months later post filter deployment, it was alleged that the filter strut detached, 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 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 Key12187691
MDR Text Key262156852
Report Number2020394-2021-80577
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031328
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF048F
Device Lot NumberGFOL2716
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2005
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: 07/19/2021 Patient Sequence Number: 1
Treatment
ACETAMINOPHEN AND ATORVASTATIN; CLOPIDOGREL, HYDROXYZINE AND LISINOPRIL
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