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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 Problem Migration or Expulsion of Device (1395)
Patient Problem Death (1802)
Event Date 05/13/2016
Event Type  Death  
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. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Bard retrievable filter was implanted at the level. Approximately eight years and two months post filter deployment, a computed tomography revealed the filter which terminates at level. Subsequently, a few years later patient expired due to multiple organ system failure, cor pulmonale, recurrent pulmonary embolism and antiphospholipid antibody syndrome. Therefore, the investigation is confirmed for filter migration. Based on 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: 07/2010).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with recurrent pulmonary embolism. Approximately eight years and one month later post filter deployment, it was alleged that the filter migrated. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient reportedly expired.

 
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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 Key10256784
MDR Text Key198286897
Report Number2020394-2020-04382
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062887
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 07/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF310F
Device LOT NumberGFRF3472
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/05/2007
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: 07/10/2020 Patient Sequence Number: 1
Treatment
ELIQUIS
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