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

Catalog Number UNKNOWN FILTER

Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history record (dhr) 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.Approximately ten and half months post filter deployment, ct revealed a linear radiopaque density within the right renal hilum which appeared to be within renal artery and most likely represented an embolized fragment of the ivc filter.Also, the ivc filter was positioned with majority of the filter above the level of renal veins.Subsequent radiopaque density seen on prior radiograph also revealed, a detached fragment of the ivc filter was not appreciated on this exam and may have changed its location.Nine days later, the patient presented with abdominal pain and back pain.Subsequent ct revealed, presence of filter fragments in the parenchyma and not in iliac or renal vasculature.Approximately one year later, ct revealed filter partially displaced but there was no evidence of perforation or inflammation.Eventually a year later, ct revealed the presence of fractured filter struts as seen in previous examinations.The ivc filter was identified with its apex approximately 7.5mm superior to the point of entry of the left renal vein.The position remained unchanged from previous examinations.Also, there appeared to be 2 rows of struts.A more superior row of struts had only one of them present at this time and these appeared to be within the confines of the ivc and adjoining renal vein.A more inferior row of struts appeared to extend beyond the confines of the ivc wall and most likely represented some caval perforation from these struts.Conceivably one of these struts had fractured and has extended into the region of the right renal hilum and is unchanged from previous examinations.There is also noted a metallic wire within the right lower lobe pulmonary artery which is felt to be secondary to embolization of a strut into the right lower lobe pulmonary artery following a fracture of a strut from the ivc filter.Therefore, the investigation is confirmed for filter limb detachment, perforation of the ivc and unintended movement.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.

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 detached and struts perforated into the organs.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.

• 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 NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9449170
• MDR Text Key: 170214062
• Report Number: 2020394-2019-05436
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2019

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: 11/22/2019
• Initial Date FDA Received: 12/11/2019
• 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
• Treatment: AMLODIPINE, ASTELIN, HYDROCODONE-ACETAMINOPHEN; LISONOPRIL, MELOXICAM, NEURONTIN, OXYCODONE; PRAVASTATIN, PRILOSEC; VITAMIN D, LOVENOX, COUMADIN
• Patient Outcome(s): Other
• Patient Weight: 77