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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 Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the (b)(4) 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. Radiological finding showed the filter came out of its lumen. Incidentally found on a subsequent hospitalization that the filter was migrated. The patient experienced abdominal pain at and around the hernia site and worsen than back pain. A recent computed tomography scan showed the filter was out of place and embedded on aorta. Therefore, the investigation is confirmed for perforation of the inferior vena cava and filter migration. However, the investigation is inconclusive for filter tilt. 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. Medical device - expiry date: 02/2013.

 
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 the filter tilted, migrated to heart and struts perforated. The device has not been removed and there were no reported attempts made to retrieve the filter. 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 Key10372277
MDR Text Key201837089
Report Number2020394-2020-05279
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 08/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF310F
Device LOT NumberGFUA4054
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/10/2010
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: 08/06/2020 Patient Sequence Number: 1
Treatment
LOPRESSOR
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