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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM; VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN G2
Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
Manufacturer Narrative
No device, no medical records, or no medical images were provided to the manufacturer.The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The investigation of the reported event is currently underway.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 eight years and ten months post deployment of a vena cava filter, a kub x-ray allegedly demonstrated one of the filter's limbs as fragmented or bent.The filter was reported as appropriately positioned.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.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: no medical images have been made available to the manufacturer.Conclusion: the device was not returned.Images and medical records were not provided.The investigation is inconclusive for filter limb detachment and material deformation.Based upon the available information the definitive root cause for this event 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 eight years and ten months post deployment of a vena cava filter, a kub x-ray allegedly demonstrated one of the filter's limbs as fragmented or bent.The filter was reported as appropriately positioned.There was no reported patient injury.
 
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Brand Name
G2 FILTER SYSTEM
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 Key6138882
MDR Text Key61243612
Report Number2020394-2016-01124
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/08/2016
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 NumberUNKNOWN G2
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/08/2016
Initial Date FDA Received12/01/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/05/2017
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
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