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

Catalog Number RF048F

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Chest Pain (1776)

Event Date 06/26/2015

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 in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter struts detached and retained in lung base.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced chest pain; however, the current status of the patient is unknown.

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 eleven years post filter deployment, x-ray chest posteroanterior and lateral revealed there was a linear metallic approximately 2.2 cm tiny foreign body, probably in the right lower pulmonary artery.Broken limb of the inferior vena cava filter with pulmonary dislodgment was suspected.Approximately one year later, chest single view revealed small linear radiopaque foreign body within the medial right lower lobe consistent with broken limb from the patient¿s inferior vena cava filter that extended into the right lower lobe pulmonary artery.Subsequently, a few days later computed tomography revealed there was a small linear metallic density noted in right lower lobe posterior or medial basilar subsegmental artery consistent with prior fracture of a strut of the inferior vena cava filter with migration of a strut into the pulmonary arterial tree.Approximately one month later, the patient visited the hospital with the compliant of sharp stabbing chest pain and shortness of breath and radiation to the right breast.Therefore, the investigation is confirmed for filter limb detachment.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 in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter struts detached and retained in lung base.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced chest pain; 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: 10776482
• MDR Text Key: 214307312
• Report Number: 2020394-2020-06386
• 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,Followup
• Report Date: 11/25/2020

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: RF048F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 11/25/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 31 YR