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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 Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 11/15/2016
Event Type  Injury  
Event Description
It was reported that approximately seven years five months post filter deployment, the filter was retrieved; however, one detached filter limb remains in the patient. The location of the detached limb is unknown. The patient status was not provided. New information: 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 and embedded the wall of the ivc and detached. The device was removed percutaneously. The status of the patient is unknown.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only event reported to date for this lot number and failure mode. Medical record review:a vena cava filter was deployed for a preoperative diagnosis of recurrent dvts despite being on coumadin. It was noted the patient often noncompliant with coumadin. The deployed filter was placed via the common femoral vein. Inferior venacavogram performed during filter indicated placement at about the level of l2. The patient tolerated the procedure well. Approximately three and a half years post ivc deployment, the patient presented with leg swelling, an ultrasound confirmed a deep vein thrombosis of the left lower extremity. Due to patient experiencing leg pain one and a half years later, a repeat ultrasound revealed evidence of chronic deep vein thrombosis in the bilateral lower extremities. Approximately seven and a half years post ivc deployment, the patient presented with chronic embolism and thrombosis of both lower extremities. A ct of the abdomen and pelvis revealed good position of the ivc filter below the renal veins with the tip of the filter at the level of l2. Also indicated was perforation of the ivc with the ivc filter struts extended outside the wall. Fifteen days later, via the right internal jugular vein there was multiple unsuccessful attempts using a recovery cone retrieval system. The filter was successfully retrieved using a crocodile jaw forceps system with moderate difficulty. The visual inspection of the retrieved filter demonstrated the main body of the filter with some attached filter legs/struts. A ct scan and repeat cavogram demonstrated a small portion of retained legs/struts were protruding through the ivc wall. Retrieval was not attempted to remove the legs/struts due to the increase of injury, bleeding and pain. A repeat cavogram verified no thrombus, no ivc abnormality, or extravasation. Pathology report indicated retrieved ivc filter measuring measuring 4. 5 cm in length by 3. 0 cm in diameter. There are nine metallic struts that are smooth and shiny. One of the 9 struts appears to be broken. There is also an apparent strut missing. Approximately one month post filter retrieval, patient reports left-sided back and lower extremity shooting paints. Cta of the abdomen and pelvis demonstrated retained fractured filter legs within the l2/l3 anterolateral intervertebral disc space. No evidence of retroperitoneal hematoma. Stable left femoral vein calcification and extensive collateral veins within the lower anterior abdominal wall, draining left lower extremity to the contralateral side, suggesting chronic left femoral/iliac vein thrombosis. Patient to follow up with surgeon regarding alternative options to remove the retained struts. Investigation summary: the device was not returned for evaluation. Images were not provided for review. Medical records were provided and reviewed. Approximately seven and a half years post ivc deployment, a ct revealed perforation of the ivc with the filter struts extending outside the wall. Visual inspection post filter retrieval demonstrated the main body of the filter with some attached filter struts. Pathology report indicated nine metallic struts with one of the struts noted to be broken. Approximately one month post filter retrieval, a ct demonstrated retained fractured filter legs within the l2/l3 anterolateral intervertebral disc space. Therefore, the investigation can be confirmed for perforation of the ivc and limb detachment. However, the investigation is inconclusive for filter tilt. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: warnings: filter fractures are a known complication of vena cava filters. There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques 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: 01/2012, manufacturing date: 01/2009. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Manufacturer Narrative
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: as medical images were not provided, a review could not be performed. Conclusion: the device was not returned. Images and medical records were not provided. The investigation is inconclusive for the reported event. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: warnings/potential complications: filter fractures are a known complication of vena cava filters. There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that approximately seven years five months post filter deployment, the filter was retrieved; however, one detached filter limb remains in the patient. The location of the detached limb is unknown. The patient status was not provided.
 
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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 Key6212629
MDR Text Key294591044
Report Number2020394-2016-01213
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF310F
Device Lot NumberGFSL1258
Was Device Available for Evaluation? No
Date Manufacturer Received04/25/2022
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: 12/29/2016 Patient Sequence Number: 1
Treatment
COUMADIN, ATENOLOL, CELECOXIB, LAMOTRIGINE,; COUMADIN, ATENOLOL, CELECOXIB, LAMOTRIGINE,; LOSARTAN, LOVASTATIN, METOPROLOL, PRISTIQ; LOSARTAN, LOVASTATIN, METOPROLOL, PRISTIQ; SIMVASTATIN, SUMATRIPTAN, SEPARARE, VITAMINS; SIMVASTATIN, SUMATRIPTAN, SEPARARE, VITAMINS
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