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

Catalog Number UNKNOWN FILTER

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682)

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

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the reported lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Post filter deployment, using the cook retrievable system, snaring of the filter was attempted.After multiple tries with over 20 minutes of fluoroscopy time and using different oblique view, the filter hook was still unable to be grasped.A smaller snare was also used but unsuccessful.Through the right common femoral vein approach, angioplasty balloon and venoplastied the inferior vena cava attempting to push the filter off the sidewall and breaking up any sort of scarring.Multiple attempts were performed.The balloon was even snared and attempt to bring that down over the hook of the filter was unsuccessful.During another fluoroscopy, the filter appeared to be quite scarred in and the positioning of the hook was still at the sidewall of the inferior vena cava.The filter was not able to be retrieved.Around one year and three months later, a computed tomography of abdomen showed the filter at the upper apex of the biceps at the l2-l3 disc space extending to l4.The device was located in the posterior margin of the inferior vena cava.A few of the lower limbs extended just peripheral to the inferior vena cava.Inferior on the left approximately 3 mm peripherally to the vena cava and approximately 2 mm from the aorta.Unsuccessful complex retrieval due to tilt and scarring.Multiple perforations.Therefore, the investigation is confirmed for the reported perforation of vena cava, filter tilt and unable to retrieve the filter.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.H3 other text : device not returned.

Event Description

It was reported through the litigation process that an inferior vena cava filter was placed in a patient after being diagnosed with an unknown medical condition.At some time, post filter deployment, it was alleged that the filter had tilted and the filter struts had perforated the inferior vena cava.It was further reported that the device was unable to retrieve.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: 18578180
• MDR Text Key: 334376272
• Report Number: 2020394-2024-00116
• 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
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• 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
• Date Manufacturer Received: 01/03/2024
• 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 Age: 55 YR
• Patient Sex: Female