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

Catalog Number UNKNOWN FILTER

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

Patient Problem Abdominal Pain (1685)

Event Date 02/15/2019

Event Type  Injury  

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 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 deployed for a patient with an unknown medical condition.Sometimes post the filter deployment, it was alleged that a filter strut was allegedly detached, and the detached strut perforated the inferior vena cava, located external to the inferior vena cava.Reportedly, the patient allegedly experienced abdominal pain, however the current status of the patient is unknown.

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.The medical records included images.The image review was documented in the medical records.One image was reviewed.The xray image demonstrates an inferior vena cava filter adjacent to the lumbar spine.This is a plain film with no contrast so ability to assess tilt is limited.Furthermore, perforation is unable to be discerned.The struts all appear intact, and the filter appears to have no tilt.There does appear to be a strut that has perforated and migrated to the right of the vena cava.Medical records were provided and reviewed.Post filter deployment, an x-ray abdomen was performed for vaginal bleeding showed the filter was in place.Around fourteen years and ten months later, an x-ray lumbar spine was performed with history of spondylosis of lumbar region showed that the filter was noted to the right of l2.However, there is a thin linear metallic density measuring roughly 27 mm in length seen inferior lateral to the filter which may represent a fracture dislodged filter strut located external to the ivc.Around seven months and eighteen days later, mri abdomen, ct chest study was again reviewed and showed that the recovery filter was noted at l2-l3 location.There was no caudal or cephalad migration, no filter tilt and strut perforation was identified.There was a fractured or missing filter component noted at least 2 arms.Therefore, the investigation is confirmed for the reported perforation of inferior vena cava, and filter strut detachment.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.

Event Description

It was reported through the litigation process that a vena cava filter was deployed for a patient with an unknown medical condition.Sometimes post the filter deployment, it was alleged that a filter strut was allegedly detached, and the detached strut perforated the inferior vena cava, located external to the inferior vena cava.Reportedly, the patient allegedly experienced abdominal pain, however the current status of the patient is unknown.

• 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: 18289305
• MDR Text Key: 329993923
• Report Number: 2020394-2023-01174
• 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: 12/10/2023

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: UNKNOWN FILTER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 12/10/2023
• Supplement Dates FDA Received: 12/12/2023
• 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 Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female