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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 RF400F
Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423)
Patient Problems Occlusion (1984); Swelling (2091); Thrombosis (2100)
Event Date 04/16/2015
Event Type  Injury  
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: the patient with lower extremity dvts was indicated for vena cava filter placement. Access was gained to the right common femoral vein and a venacavagram demonstrated a vena cava diameter less than 23 mm with no anomalies and no clot. The filter was successfully deployed just below the lowest renal vein without incident. A post placement radiograph demonstrated good position of the filter. Compression was applied to the access site until hemostasis was achieved. Approximately six years post filter deployment, the patient presented to the hospital with severe right lower extremity swelling. A ct scan demonstrated complete thrombosis from the ivc filter from the infrarenal ivc down the right leg and just to the left common iliac vein. It was recommended that catheters be placed and thrombolysis performed. The left common femoral vein was accessed and a cavogram demonstrated complete occlusion of the left common iliac vein as well as the inferior vena cava with reconstitution of the renal vena cava. An infusing catheter was placed from the ivc filter down into the left common iliac system. The popliteal veins were accessed and a right venogram was performed showing some nonocclusive thrombus of the femoral vein. A venacavagram was performed from the external iliac vein and showed complete occlusion of the vena cava system as well as the iliacs. A wire was transversed into the ivc filter and another lysis catheter was placed from below the treatment zone from the left side into the right common iliac system. The rate of infusion was set and the procedure was completed. The patient tolerated the procedure well without complications. The plan was to monitor the patient overnight and possibly intervene with more treatment the following day. Image/photo review: as medical images were not provided, a review could not be performed. Conclusion: the device was not returned. Images were not provided. Medical records were provided and reviewed. A vena cava filter was successfully deployed. Six years post filter deployment a ct scan demonstrated complete thrombosis from the ivc filter from the infrarenal ivc down the right leg and just to the left common iliac vein. Based on the medical records the investigation can be confirmed for occlusion within the device. Based upon the available information the definitive root cause for this event is unknown. Labeling review: the current ifu (instructions for use) states: warnings: note: it is possible that complications such as those described in the "warnings", "precautions," or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted. Potential complications: - caval thrombosis/occlusion. 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
Medical records were received and reviewed. Approximately six years post vena cava filter deployment indicated for lower extremity dvt, the patient presented with right lower extremity swelling. Imaging demonstrated complete thrombosis of the vena cava from the filter to the iliac veins. Subsequent chemical thrombolysis of the iliocaval system was performed. The patient tolerated the procedure well without complications. The plan was to monitor the patient and possibly intervene with more treatment the following day. No additional information surrounding this event was provided in the medical records received.
 
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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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key6263531
MDR Text Key65258819
Report Number2020394-2017-00008
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,Followup
Report Date 02/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF400F
Device Lot NumberGFTC4541
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2019
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: 01/19/2017 Patient Sequence Number: 1
Treatment
LOVENOX
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