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

Catalog Number RF048F

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

Patient Problems Chest Pain (1776); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the 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.Approximately ten years post filter deployment, patient presented with chest pain.Subsequent, computed tomography revealed a retained fragment of the inferior vena cava filter in the right ventricle.Eventually, chest x-ray 2 revealed linear metallic density projected within the anterior left lung, possible of embolized inferior vena cava filter fragment.After two days, computed tomography revealed there was a linear angulated metallic foreign body along the free wall of the right ventricle.This corresponded to the previously seen anterior and medial foreign body on the comparison radiograph.Within a subsegmental pulmonary artery which supply the anterior aspect of the left lower lobe, there was a linear angulated metallic foreign body that measured approximately 1 mm in diameter.This corresponded to the previously seen more lateral metallic foreign body seen on the comparison radiograph.There was a 5 mm metallic density posterior to the liver.Based upon the location and appearance, this was favored to represent a surgical clip.There was an infrarenal inferior vena cava filter with 4 upper angulated legs and 6 lower legs present.Subsequently, next day echocardiogram revealed linear metallic density that measured 1.5-2.0 cm was seen along the mid to apical right ventricle free wall and a smaller segment at the right ventricle apex.Approximately three months and five days later, computed tomography revealed a linear metallic structure that measured approximately 2.4 cm in length in right ventricle along the anterior wall was stable.On the same day, computed tomography revealed the presence of inferior vena cava filter.Therefore, the investigation is confirmed for filter limb detachment and material deformation.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 right common femoral deep vein thrombosis.At some time post filter deployment, it was alleged that the filter struts detached and material deformed.The detached strut was retained in the right ventricle and another strut projected within the anterior left lung.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced chest pain and diagnosed with small pericardial effusion; however, the current status of the patient is unknown.

• Brand Name: RECOVERY FILTER SYSTEM
• 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: 10552414
• MDR Text Key: 207503796
• Report Number: 2020394-2020-05697
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031328
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF048F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• 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: KEPPRA
• Patient Outcome(s): Other
• Patient Weight: 63