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 02/18/2021

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 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 deployed for a patient with an unknown medical condition.It was furer reported that sometimes post the filter deployment, the inferior vena cava filter was allegedly tilted and struts perforated the vena cava wall.Furthermore, one of the filter arm was allegedly detached.The device has not been removed, and there have been no reported attempts made to retrieve the filter.There was no reported patient injury.

Event Description

It was reported through the litigation process that a vena cava filter was deployed for a patient with an unknown medical condition.It was further reported that sometimes post the filter deployment, the inferior vena cava filter was allegedly tilted and struts perforated the vena cava wall.Furthermore, one of the filter arm was allegedly detached.The device has not been removed, and there have been no reported attempts made to retrieve the filter.There was no reported patient injury.

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.Medical records were provided and reviewed.Post filter deployment, a computed tomography of abdomen showed that the filter tip is 1.5 cm below the lower left renal vein.The filter axis is forming 12-degree anterior angulation compared to the inferior vena cava axis.There is evidence of posterior struts penetration up to 15 mm away from the inferior vena cava wall.No evidence of detected struts migration.Fracture of single struts was noted with cranial angulation.Around eight months and twenty-three days later, the computed tomography of abdomen study results showed the filter was located at l3 position.No filter migration was noted.Filter was tilted >15 degrees.Filter apex/hook embedded the anterior caval wall.Filter strut perforation >3 mm was noted with 3 arms and 3 legs.Penetration into the anterior aspect of l3 vertebral body and l3-l4 disc with hypertrophic boney reactive changes.Impingement on overlying small bowel.One filter arm was malpositioned and directed cephalad within the ivc lumen.Possibly fractured.Therefore, the investigation is confirmed for the reported perforation of vena cava wall, filter tilt 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.H10: g3, h6 (method).H11: h6 (result, conclusion).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.

• 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: 18289226
• MDR Text Key: 330133407
• Report Number: 2020394-2023-01172
• 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?: 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: 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 Age: 60 YR
• Patient Sex: Male