MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number MD800F

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Thrombus (2101); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)

Event Date 10/10/2012

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Medical record review: a patient with a history of deep vein thrombosis and pulmonary embolism with contraindication for anticoagulation, following a motorcycle accident with head injury was hospitalized.Approximately five days post hospital admission, the patient had a vena cava filter deployed.Approximately twenty days post filter deployment, the patient has a ct scan of the abdomen and pelvis, which noted a large thrombus within the inferior vena cava at the level of the filter, extending superiorly to the level of the right hepatic vein.In addition, there was venous thrombus within the right femoral vein and right external iliac vein.The patient was started on an anticoagulation drip and discharged one month later.Approximately two years seven months post filter deployment, the patient had a chest x-ray, which noted a wire-like object projected over the right hemithorax representing a retained filter fragment within the right lung or soft tissues.Approximately three years two months post filter deployment, the patient presented for filter retrieval.The filter and a detached filter limb embedded in the inferior vena cava were retrieved.No attempt was made to retrieve the detached filter limb in the lung.Investigation summary: approximately twenty days post filter deployment, the patient has a ct scan of the abdomen and pelvis, which noted a large thrombus within the inferior vena cava at the level of the filter, extending superiorly to the level of the right hepatic vein.Approximately two years and seven months post filter deployment, the patient had a chest x-ray, which noted a wire-like object projected over the right hemithorax representing a retained filter fragment within the right lung or soft tissues.Repeat anterior-posterior cavograms were performed which noted two fractured filter limbs.Therefore, the investigation is confirmed for the alleged detachment of filter limbs.It can also be confirmed that there was thrombosis above the filter after implantation.Based upon the available information, the definitive root cause is unknown.Labeling review: the current instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.The information provided by bard 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 bard.

Event Description

It was reported through the litigation process that a vena cava filter was placed in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, allegedly filter limbs detached.The filter and a detached limb were removed percutaneously; however, a detached limb remains embedded in the lung.The current patient status 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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.On the next day of post-deployment, an x-ray abdomen was performed which showed interval placement of inferior vena cava filter, projecting just to the right of the midline at the level of l1.After, seventeen days, computed tomography of the abdomen and pelvis was performed which showed a large thrombus within the inferior vena cava at the level of the inferior vena cava filter, extending superiorly to the level of the right hepatic vein.Inferior vena cava filter and thrombus were present at the level of the renal veins.An x-ray of the abdomen was performed which showed several of the inferior vena cava filter limbs have become distorted when compared to the prior study.Around, one month and four days later, the patient presented with complaints of right groin pain.Previous computed tomography of abdomen and pelvis study showed that acute thrombosis at the level of the filter.On the next day, computed tomography of the abdomen and pelvis was performed which showed previously identified filling defect involving the inferior vena cava at the level of the inferior vena cava filter, extending into the right hepatic vein, has resolved.The inferior vena cava filter was in stable positioning when compared to the previous examination.Around, two years and five months later, an x-ray chest was performed which showed 2 cm linear metallic density projects in the right perihilar region.This may be external to the patient or represent a retained fragment within the right lung or soft tissues.Computed tomography of abdomen and pelvis was performed for right chest, neck, and abdominal pain.The study showed a demonstration of an inferior vena cava filter, which was positioned at the level of right renal vein confluence.Around seven months and ten days later, the patient was planned for inferior vena cava filter retrieval.Through the right internal jugular vein approach, a cavogram was performed.One of the fractured legs was noted projecting over the right lung and the second fractured leg was noted to be entirely within the inferior vena cava.A sheath was deployed just superior to the inferior vena cava filter, a second sheath was inserted in a telescoping fashion and placed just superior to the filter.The filter was successfully captured and removed with a bard snare device.The attention was turned to the fractured leg within the inferior vena cava.Multiple attempts using a bard snare device and pigtail catheters were performed in multiple projections.A cavogram were performed and the fragment was noted to have migrated and laid horizontal across the inferior vena cava.Through the sheath, 2 mm endo jaw disposable biopsy forceps were deployed and used to successfully grasp and eventually remove the fractured leg through the sheath.The inferior vena cava filter along with the broken filter leg within the inferior vena cava was retrieved without any complications.Therefore, the investigation is confirmed for filter limb detachment and material deformation.Additionally, it can be confirmed that the patient experienced thrombus at the level of the filter post deployment.However, the relationship to the filter is unknown.Based upon 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.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 conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter limbs detached.The filter and a detached limb were removed percutaneously; however, a detached limb remains embedded in the lung.The current patient status is unknown.

• Brand Name: MERIDIAN FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7140216
• MDR Text Key: 95555478
• Report Number: 2020394-2017-01789
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K112497
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MD800F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN; COUMADIN; COUMADIN
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 49 YR
• Patient Weight: 102