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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 X FILTER SYSTEM - JUGULAR VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. G2 X FILTER SYSTEM - JUGULAR VENA CAVA FILTER Back to Search Results
Catalog Number RF400J
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 04/20/2014
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a lot history review was performed. This is the only complaint to date for this lot number. Therefore, a device history record review is not required. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately three years and two months post filter deployment, patient presented with abdominal pain. Approximately three years later, computed tomography revealed the superior central core of the filter lies just inferior to the left renal vein, which was the most inferior of the two veins. The core was aligned straight with the longitudinal access of the inferior vena cava. The struts in general pierce the outer wall of the inferior vena cava. One of the struts at approximately 2 o'clock extends anterior laterally towards the left and pass through anterior right edge of the aortic wall and terminates in the anterior central aortic wall. The strut posterior to that extends laterally at approximately 3 o'clock to 4 o'clock and terminates outside the aorta 0. 9 cm to the left of the inferior vena cava. The other struts extend outside the confines of the inferior vena cava for 0. 3 cm to 0. 4 cm each. Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc). Based upon 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. (expiry date: 11/2012).
 
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 filter struts perforated. 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 NameG2 X FILTER SYSTEM - JUGULAR
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 Key11384891
MDR Text Key233740637
Report Number2020394-2021-80208
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082305
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 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF400J
Device Lot NumberGFTJ1955
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2021
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: 02/26/2021 Patient Sequence Number: 1
Treatment
ALBUTEROL, LOPRESSOR, NITROGLYCERIN, GENTAMYCIN; CARVEDILOL, MONTELUKAST, ROSUVASTATIN, TOPIRAMATE; CIPRO, XARELTO, PROVENTIL, EPIPEN, TOPAMAX; CRESTOR, ERGOCALCIFEROL, COUMADIN, TOPIRAMATE,; DILAUDID, DEPAKOTE, BENADRYL, FIORICET, ASPIRIN; FLAGYL, LORTAB; LISINOPRIL, CLARITIN, SUMATRIPTAN SUCCINATE; OMEPRAZOLE, ELIQUIS, FEXOFENADINE, ALLEGRA; ROBAXIN, NORETHINDRONE, LEVAQUIN, EPINEPHRINE; SINGULAIR, LOVENOX, VICODIN, MOTRIN, IMITREX
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