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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR; VENA CAVA FILTER Back to Search Results
Catalog Number RF320J
Device Problems Malposition of Device (2616); Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2010
Event Type  malfunction  
Manufacturer Narrative
No medical images have been made available to the manufacturer.Medical records were provided and reviewed.As the lot number for the device was not provided, a review of the device history records will not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: the patient presented with a finding of extensive deep vein thrombosis (dvt) involving the entire right lower extremity (le) and was taken the same day for prophylactic inferior vena cava (ivc) filter placement prior to thrombectomy and thrombolysis.The right internal jugular vein was accessed and an inferior venacavogram was performed showing thrombus extending from the right common iliac vein into the ivc.The ivc more centrally was free of clot.The filter was advanced and deployed below the renal vein level.There was good centering of the filter and the legs expanded to the diameter of the cava.The patient tolerated the procedure well.Following the ivc filter placement, the patient underwent right le venous thrombectomy and thrombolysis with t-pa, and left le and iliac venogram which demonstrated a large amount of clot remaining.The following day, the right iliac vein was successfully stented to 14 mm with excellent resulting flow.The ivc filter was noted to have moved slightly more distally and was slightly tilted.Approximately four years post filter deployment, ivc filter removal was requested and authorization approved to schedule patient for procedure; however, no records were provided regarding a filter retrieval procedure.No further information was noted regarding the patient¿s current status.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 through the litigation process.The patient with deep vein thrombosis had a vena cava filter successfully deployed prior to thrombectomy and thrombolysis.The following day, a right lower extremity venogram demonstrated that the filter had moved slightly more distally and was also slightly tilted.The current patient status is unknown.
 
Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation and images were not provided for review.However, medical records were provided and reviewed.Approximately one day post filter deployment, during a lower extremity venogram, the filter was noted to have moved slightly more distally and was slightly tilted.Therefore, the investigation is confirmed for unintended movement and tilt based on the provided medical records.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: - movement, migration or tilt of the filter are known complications of vena cava filters.Migration of filters to the heart or lungs has been reported.There have also been reports of caudal migration of the filter.Migration may be caused by placement in ivcs with diameters exceeding the appropriate labeled dimensions specified in this ifu.Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens.- filter malposition - filter tilt.
 
Event Description
Medical records were received through the litigation process.The patient with deep vein thrombosis had a vena cava filter successfully deployed prior to thrombectomy and thrombolysis.The following day, a right lower extremity venogram demonstrated that the filter had moved slightly more distally and was also slightly tilted.The current patient status is unknown.
 
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Brand Name
G2 FILTER SYSTEM - JUGULAR
Type of Device
VENA 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 Key7148580
MDR Text Key95848361
Report Number2020394-2017-01810
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 01/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF320J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/30/2017
Initial Date FDA Received12/27/2017
Supplement Dates Manufacturer Received01/09/2018
Supplement Dates FDA Received01/18/2018
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 Sequence Number1
Patient Age65 YR
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