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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 Thrombosis (2100)
Event Date 05/22/2010
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: a lot history review was performed. This is the only complaint to date for this lot number. Therefore, a device history record review is not required. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately three years and ten months post filter deployment, computed tomography (ct) revealed the inferior vena cava filter was in place. After two days later, computed tomography (ct) revealed the inferior vena cava filter was in place and the filter apex projected about 4 cm above the level of the right venal vein. There was thrombosis of the inferior vena cava at and below the level of the filter. Thrombus was also noted within both internal iliac veins as well as within the superficial femoral and profunda femoral veins. After two days later bilateral lower extremity venogram, bilateral lytic catheter placement and balloon angioplasty, right superficial femoral were done. After one day later lytic check venogram and repositioning of lytic catheter were performed and the clot in the inferior vena cava was resolved. On the same day, a recovery cone was inserted and used to capture the filter which was removed without difficulty. The option filter was placed at the level of the right renal vein. Therefore, the investigation is inconclusive 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.

 
Event Description

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 filter migrated to the inferior vena cava. The device was removed percutaneously. The current status of the patient is unknown.

 
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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 Key10217270
MDR Text Key197098579
Report Number2020394-2020-04180
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 07/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF310F
Device LOT NumberGFPK1184
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2020
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: 07/01/2020 Patient Sequence Number: 1
Treatment
ALBUTEROL, DARVOCET, METHOTREXATE; CLARITIN, MULTIVITAMIN, PROTONIX; DYAZIDE, ATARAX, LISINOPRIL; LOVENOX, ELAVIL, COUMADIN; SIMVASTATIN
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