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

Catalog Number RF320J

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2012).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated, detached and tilted.The device has been removed percutaneously.The current status of the patient is unknown.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated, detached and tilted.The device has been removed percutaneously.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and 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 eight months of post-deployment, a computed tomography angio (cta) abdomen and pelvis was revealed that the filter was angulated with the tip pointing leftward and the prongs to the right, one extending into the vertebral body and one likely going into an adjacent renal vein on the left and one in the adjacent fat.After, three days, the patient was scheduled for the filter retrieval; the right internal jugular vein was accessed.The 10 french bard recovery cone system was advanced through the 12 french sheath and used to grasp and remove the filter.Despite the penetration of the filter legs outside the inferior vena cava and filter was removed easily.After removal, the filter was inspected, and it was discovered that one of the 6 arms was missing.The 6 legs were intact.The chest was examined under fluoroscopy and the fractured arm was identified in the right lung.Correlation with prior chest radiographs was revealed that the arm was in an unchanged position in the right lung.Therefore, the investigation is confirmed for the filter tilt, perforation of the inferior vena cava (ivc), and filter limb detachment.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 08/2012), g3, h6(method) h11: h6(result, conclusion) h11: section a through f ¿ the information provide by bd represents all 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 bd.Device not returned.

• 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
• MDR Report Key: 11918589
• MDR Text Key: 253810919
• Report Number: 2020394-2021-01150
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K052578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF320J
• Device Lot Number: GFTH1212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR