MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER

Catalog Number UNKNOWN FILTER

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 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: section a through f - the information provided by bd represents all of 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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with lower extremity deep vein thrombosis and pulmonary embolism.At some time, post filter deployment, it was alleged that the filter had detached, perforated, and tilted.The device has not been removed and there were no reported attempts made to retrieve the filter.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Six ct images and one plain film image of the abdomen were reviewed.The images depict an ivc filter in the inferior vena cava.The filter is incompletely imaged but at least one ¿leg¿ appears to lie separate from the body of the device.Medical records were provided and reviewed.Post filter deployment, computed tomography scan of abdomen showed the filter had tilted with apex against the caval wall.Multiple struts perforated the inferior vena cava.Two struts were fractured.One fragment remained in the vena cava, the other perforated the inferior vena cava, and projected anterior to the abdominal aorta.Review of computed tomography scan appeared to also show involvement with the vertebral body.Therefore, the investigation is confirmed for the reported perforation of inferior vena cava, filter tilt and filter limb detachment.A definitive root cause could not be determined based upon the available information.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 of 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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with lower extremity deep vein thrombosis and pulmonary embolism.At some time, post filter deployment, it was alleged that the filter had detached, perforated, and tilted.The device has not been removed and there were no reported attempts made to retrieve the filter.There was no reported patient injury.

• Brand Name: VENA CAVA FILTER
• 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 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17689554
• MDR Text Key: 322712694
• Report Number: 2020394-2023-00653
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN FILTER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/03/2023
• 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 Age: 55 YR
• Patient Sex: Female