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

Catalog Number RF320J

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

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately five years and eight months post filter deployment, an x-ray abdomen was performed which showed the filter with tip along the anterior wall.There is multifocal leg penetration and there is a fractured leg fragment extending extraluminally along the left side.There is mild inferior vena cava stenosis.Around four months later, an x-ray kub was performed for abdominal pain and loss of appetite showed that metallic filter was seen adjacent to the l3 vertebral body.Around nine months and twenty-six days later, patient was planned for filter retrieval procedure.Through the right internal jugular vein approach, a sheath was advanced to the apex of the filter.Rigid forceps were placed through the sheath.Gentle dissection was done to free the filter hook.The apex of the filter was engaged by the forceps and sheath advanced.A post-retrieval inferior vena cavogram was then performed.The filter fragment location was probed to confirm that the fragment was extraluminal.Post retrieval inferior vena cavogram demonstrates mild residual spasm of the infrarenal inferior vena cava at the site of prior filter implantation.Therefore, the investigation is confirmed for the reported perforation of inferior vena cava and filter strut detachment.Additionally, device fragments in body is confirmed because one fractured leg fragment was seen outside the inferior vena cava post-retrieval of filter.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided 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.H3 other text : device not returned.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient with thromboembolism.Approximately five years eight months later post filter deployment, it was alleged that the filter strut detached and perforated.It was further reported that patient had an abdominal pain.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.

• Brand Name: G2 FILTER SYSTEM - JUGULAR
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18424089
• MDR Text Key: 331791470
• Report Number: 2020394-2023-01349
• 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: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/02/2024
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female