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

Catalog Number UNKNOWN FILTER

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 and medical record review 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 tilted, migrated towards the heart, struts detached and perforated the inferior vena cava wall.The device has not been removed and there were no reported attempts made to retrieve the filter.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 tilted, migrated towards the heart, struts detached and perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.An inferior vena cava filter was deployed at the base of l2 and most of l3 for a patient with deep venous thrombosis and pulmonary embolus.Approximately three days of post deployment, a computed tomography of chest was performed for follow-up study after starting thrombolytic therapy, which showed a large central pulmonary embolus on the right main pulmonary artery which extends into the descending pulmonary artery and some of the small branches into the right lower lobe.There was a small amount of pulmonary embolus on the left side involving left lower lobe pulmonary artery branches and a left upper lobe pulmonary artery branch.The appearance of the pulmonary embolus was not significantly changed compared to four days back.Seven years and six months later, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that the filter was at the infrarenal inferior vena cava with normal retroperitoneum.The ultrasound abdomen was performed on the same day for abdominal pain, which showed normal study of the abdomen.One year and six months later, a computed tomography of chest for performed for recurrent dyspnea.The study showed that suspicious for pneumonia and no evidence of pulmonary embolism.One year and eight months later, a computed tomography of abdomen and pelvis was performed for abdominal pain which showed that the filter apex was at the level of the inferior aspect of l2 with normal retroperitoneum.One month later, a computed tomography of abdomen and pelvis was performed for gastric pain which showed filter was in place and prominent vessels present throughout the retroperitoneum.Eleven days later, a computed tomography of abdomen and pelvis was performed for generalized abdominal pain which showed that the filter was in place and chronic thrombosis of the inferior vena cava was noted.Three months later, a computed tomography of abdomen and pelvis was performed for filter check.The study showed that the filter was positioned below the renal veins and the filter was migrated and fractured.The filter cap was located 1 cm proximal to the renal veins and the main body of the filter was located 3 cm distal to the renal veins.All the filter struts perforated the inferior vena caval walls with one strut penetrating the posterior wall of the duodenum and another strut touching the abdominal aorta.The remainder of the struts lie within the pericaval fat.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc), filter migration, and filter limb detachment.However, the investigation is inconclusive for filter tilt.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.H10: g3, h6(method) 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: 11640544
• MDR Text Key: 244617884
• Report Number: 2020394-2021-80286
• 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: 06/09/2021

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: 03/15/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention