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

Catalog Number UNKNOWN FILTER

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Pain (1994); Thrombus (2101)

Event Date 09/20/2011

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts detached.The device and the detached struts were removed percutaneously.The patient experienced pain caused by filter detachment; however, the current status of the patient is unknown.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts detached.The device and the detached struts were removed percutaneously.The patient experienced pain caused by filter detachment; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review:a device history record review could not be performed as the lot number is unknown.Investigation summary:the device was not returned for evaluation.Medical records were provided and reviewed.After post filter deployment a computed tomography angio (cta) was performed and it revealed that there are large pulmonary emboli identified in the distal aspect of the right and left main pulmonary arteries with pulmonary arterial defects extending into bilateral lower lobes, right middle lobe, lingular, and bilateral upper lobe pulmonary arteries.After two days later, an inferior vena cavogram was performed and it revealed inferior vena cava thrombus extending from the level of the filter into the suprarenal inferior vena cava for about 6cm above the filter level.The thrombus was nonocclusive but severely flow-limiting.Inferior vena cava below the filter was also widely patent without no thrombus.The filter appears slightly deformed with some of the struts extending into the suprarenal inferior vena cava.Catheter directed thrombolysis initiated.One the next day imaging demonstrated that the filling defect through the inferior vena cava, extending into the common iliac vein.It extends approximately 1 cm downstream from the tip of the vena cava filter.The patient¿s inferior vena cava filter was a bard type optional retrievable filter.The securing legs are intact, but the positioning legs has displaced.One leg extends into the renal vein on the left and the other leg projects outside the walls of the inferior vena cava on the right, and a third leg extends superiorly.Angio jet mechanical thrombectomy was performed through the inferior vena cava and common iliac vein.A follow up venogram was performed and it revealed there was additional thrombus within the common iliac vein, but it was non obstructed to flow.Approximately seven days later, the patient scheduled for the filter retrieval; the right internal jugular vein was accessed.The venogram was performed which showed stable position of the deformed bard eclipse type filter.Filling defect was present in the inferior vena cava above the level of the renal veins, extending above the location of the vena cava filter.It was small, measuring approximately 2.5x0.6 cm.Retrieval snare was advanced to engage the hook on the top of the filter.Once this was captured, the sheath was advanced over the filter, drawing the legs inward.Using gentle rotational motion and forward pressure on the sheath, the filter was captured and retrieved successfully.The filter was inspected and was found to have a complete fracture of one of the positioning legs, but the fracture limb had been retrieved intact with the snare device.All components of the filter were present.Fluoroscopic images showed no radiopaque retained foreign bodies.Therefore, the investigation is confirmed for filter limb detachment, perforation of the inferior vena cava (ivc) and material deformation.Additionally, it can be confirmed that the patient experienced thrombus above the filter and pe post deployment.However, the relationship to the filter is unknown.Based on the available information, the definitive root cause is unknown.Labeling review:a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: g4 h11:h6(result and conclusion) 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.

• 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
• MDR Report Key: 10858464
• MDR Text Key: 216831789
• Report Number: 2020394-2020-06421
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RANITIDINE; RANITIDINE; RANITIDINE
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 35 YR