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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 Patient Device Interaction Problem (4001)
Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685)
Event Date 10/29/2015
Event Type  Injury  
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. Approximately seven years and two months of post deployment, the patient was found to have a personal history of pulmonary embolism. On the same day, a computed tomography (ct) venogram showed 1 strut of the inferior vena cava filter extended into the duodenum and there was a doubt in the etiology of prior abdominal pain. Around three years and two months later, contiguous axial images using computed tomography (ct) abdomen and pelvis with intravenous and oral contrast showed that there was no evidence of inferior vena cava thrombosis. An infrarenal inferior vena cava filter was noted. At least 1 strut of the filter appeared to penetrate the wall of the inferior vena cava, and might have extend into the third portion of the duodenum or the periduodenal soft tissues. Therefore, the investigation is confirmed for the perforation of the ivc. Additionally, it can be confirmed that the patient experienced pe post deployment. However, the relationship to the filter is unknown. 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: 08/2011).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure. At some time post filter deployment, it was alleged that the filter struts perforated into the organs. 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 Key12180731
MDR Text Key261939142
Report Number2020394-2021-80571
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 07/16/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF310F
Device LOT NumberGFSG3096
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/05/2008
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: 07/16/2021 Patient Sequence Number: 1
Treatment
DIGOXIN AND ELIQUIS
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