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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 Problems Malposition of Device (2616); Extrusion (2934)
Patient Problem Pulmonary Embolism (1498)
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. Medical records review: the patient with history of massive pulmonary embolism had a retrievable inferior vena cava (ivc) filter deployed within the infrarenal ivc at the approximate level of l2. There were no complications. Investigation summary: the device was not returned for evaluation. Images were not provided for review. Medical records were provided and reviewed. There was no specific deficiency alleged in the provided medical records. Therefore, the investigation is inconclusive for tilt and perforation as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based upon 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. 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 through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and in conjunction with trauma situation/motor vehicle accident. At some time post filter deployment, it was alleged that the filter struts had perforated into the organs and the filter tilted and was embedded in wall of the ivc. The patient experienced a pulmonary embolism post filter implant. The device has not been removed and there were no reported attempts made to retrieve the filter. The status of the patient is unknown.

 
Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. Medical records review: the patient with history of massive pulmonary embolism had a retrievable inferior vena cava (ivc) filter deployed within the infrarenal ivc at the approximate level of l2. There were no complications. Investigation summary: the device was not returned for evaluation. Images were not provided for review. Medical records were provided and reviewed. There was no specific deficiency alleged in the provided medical records. Therefore, the investigation is inconclusive for tilt, perforation, and pe as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based upon 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. 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 through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and in conjunction with trauma situation/motor vehicle accident. At some time post filter deployment, it was alleged that the filter struts had perforated into the organs and the filter tilted and was embedded in wall of the ivc. The patient experienced a pulmonary embolism post filter implant. The device has not been removed and there were no reported attempts made to retrieve the filter. The 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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7580688
MDR Text Key110445785
Report Number2020394-2018-00819
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 ATTORNEY
Type of Report Initial,Followup
Report Date 06/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF310F
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
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 TREATMENT DATA
Date Received: 06/07/2018 Patient Sequence Number: 1
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