• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR VENA CAVA FILTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR VENA CAVA FILTER Back to Search Results
Catalog Number RF320J
Device Problems Difficult to Remove (1528); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Atrial Fibrillation (1729)
Event Date 10/12/2010
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 record review: a vena cava filter was deployed for a patient with a lower extremity dvt with prior history of life-threatening pulmonary emboli and required knee surgery. The deployed filter was placed infrarenal via the right internal jugular vein. Inferior venacavogram was performed to verify placement, the patient tolerated the procedure well without complications. Approximately eight months post filter deployment the patient presented with atrial fibrillation and was converted to sinus rhythm. Approximately two years post filter deployment the patient was admitted for lap band surgery and hiatal hernia repair, coumadin was withheld. Inr was 1. 5, hemoglobin 14. 4, and hematocrit 21. 2. The patient was discharged four days later with a prescription of arixtra. Three months later, the patient presented for ivc filter retrieval via the right internal jugular vein. A radiograph demonstrated the filter terminating at the level of l3, filter in good position without significant angulation. Ultrasound indicated a normal caliber ivc. Venagram indicated renal vein influx at level l1, no thrombus around filter, some of the medical prongs of the filter projected outside of the lumen of the inferior vena cava. No contrast extravasation identified. Due to the extra luminal component of the prongs and length of time the filter has been implanted, the decision was made to not remove the filter. Approximately three and a half years post filter deployment the patient presented with pneumonia and atrial fibrillation with rapid ventricular rate. The patient¿s medication was adjusted, patient¿s condition was to be discussed with another doctor for possible future cardioversion and/or ablation. Investigation summary: the device was not returned for evaluation. Images were not provided for review. Medical records were provided and reviewed. Approximately eight months post filter deployment, the patient presented with atrial fibrillation and was converted to sinus rhythm. Approximately two years and three months post filter deployment, the patient presented for ivc filter retrieval. Venagram indicated some of the prongs of the filter projected outside of the lumen of the inferior vena cava. Due to the extra luminal component of the prongs and length of time the filter has been implanted, the decision was made to not remove the filter. Therefore, the investigation can be confirmed for perforation of the ivc. However, the investigation is inconclusive for retrieval difficulties. 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.

 
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 or before orthopedic procedure. At some time post filter deployment, it was alleged that the ivc filter perforated and became and embedded in the ivc. The patient allegedly has had repeated bouts of atrial fibrillation, and has experienced pain. The device is unable to be retrieved, after an attempted but unsuccessful percutaneous removal procedure. The current status of the patient is unknown.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameG2 FILTER SYSTEM - JUGULAR
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 Key8066048
MDR Text Key127062359
Report Number2020394-2018-02012
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052578
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 11/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF320J
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2018
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: 11/13/2018 Patient Sequence Number: 1
-
-