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

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.

• Brand Name: G2 FILTER SYSTEM - JUGULAR
• Type of Device: VENA 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 Key: 8066048
• MDR Text Key: 127062359
• Report Number: 2020394-2018-02012
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF320J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 39 YR