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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF310F
Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Date 05/25/2016
Event Type  Injury  
Manufacturer Narrative
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. The medical records included images. The image review was documented in the medical records. Medical records were provided and reviewed. Approximately nine years of post deployment, computed tomography of abdomen showed that an inferior vena cava filter was present with the superior filter apex located 1. 9 cm inferior to the right renal vein. The proximal filer contacted the anterior wall of the inferior vena cava with an anterior tilt measured approximately 20 degrees. There were multiple struts with exited appearance from the inferior vena cava. A posterior right-sided inferior vena cava strut exited the inferior vena cava for 1. 7 cm extended towards the lumbar spine and contacted an osteophyte from the lumbar spine. There was a second posterior left sided strut which exited the inferior vena cava 0. 9 cm contacted osteophyte of the lumbar spine and extended into the right psoas muscle. An adjacent strut exited the inferior vena cava 0. 7 cm and coursed posterior to the abdominal aorta. An anterior strut exited left of midline 0. 5 cm. An anterior strut exited 0. 5 cm and contacted a posterior wall of small bowel without intraluminal extension. Along the right lateral aspect of the inferior vena cava, a strut exited 0. 7 cm and contacted the ventral surface of the right ureter. A small metallic density within the right psoas muscle measured 0. 2 x 0. 2 cm. This was below the level of the inferior vena cava strut and might represent a small fracture of the strut. The inferior vena cava was normal in caliber without stenosis. Therefore, the investigation is confirmed for filter tilt, filter limb detachment and perforation of 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: 03/2011).
 
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 the filter tilted, strut detached and perforated. It was further reported that the right -sided exited strut contacts right ureter, posterior struts contact spine and anterior strut contacts posterior wall of small bowel. 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 FILTER SYSTEM - FEMORAL
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 Key12090049
MDR Text Key259129620
Report Number2020394-2021-80532
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062887
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 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF310F
Device Lot NumberGFSA3586
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: 06/30/2021 Patient Sequence Number: 1
Treatment
COUMADIN, PRILOSEC, SINGULAIR, LOVENOX; LEXAPRO, ULTRAM, KEFLEX, TRAZODONE; TYLENOL, IBUPROFEN, DARVOCET; ZANTAC, FLONASE, AND VITAMIN K
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