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); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 03/08/2017

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 eleven years and six months of post deployment, computed tomography of the abdomen and pelvis revealed the filter was in the infra-renal inferior vena cava.The tip of the filter was positioned at the level of the right pedicle of l2.The superior aspect of the filter was 10 mm distal to the right renal vein.One of the filter struts appears broken and along the right anterior lateral inferior vena cava wall superior to the filter at the 10 o'clock position.The distal aspect of the other struts had perforated the inferior vena cava.One of the struts was within the third portion of the duodenum.Fractured, embolized arm of filter in superior right ventricle of heart at the origin of the main pulmonary artery.Fractured arm of filter adjacent to and slightly superior to the tip of the filter along the right lateral wall of the inferior vena cava.Four arms attached to filter.Six legs attached to filter.2 o¿clock arm with grade 3 penetration of the inferior vena cava into the third portion of the duodenum.5 o¿clock leg with grade 3 penetration of the inferior vena cava into the anterior third vertebral body.All other legs and arms with grade 2 penetration of the inferior vena cava.No significant tilt.Therefore, the investigation is confirmed for filter limb detachment and perforation of the inferior vena cava (ivc).Based on 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 struts detached and perforated the wall of the inferior vena cava into the third portion of the duodenum and another strut penetrated into the anterior third vertebral body.The device has not been removed and there were no reported attempts made to retrieve the filter.The detached strut embolized in superior right ventricle of the heart at the origin of the main pulmonary artery.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: 12022754
• MDR Text Key: 257447066
• Report Number: 2020394-2021-80514
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• 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: 06/08/2021
• 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: 45 YR