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

Catalog Number RF048F

Device Problems Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problem Death (1802)

Event Date 07/26/2005

Event Type  Death  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, thirteen years later computed tomography revealed that there was an inferior vena cava filter in place with tip 4 mm inferior to lowest renal vein.The filter apex was relatively well centered in the inferior vena cava with approximately 4 degrees posterior tilt.The 6 centering arms and 6 legs were intact without strut fracture or bending.At least 4 of the centering arms perforated the inferior vena cava into the surrounding fat, with the anterior limb abutting but not perforating the duodenum.This arm extended furthest from the inferior vena cava wall with 5.5mm between the strut and the inferior vena cava.The remaining 2 arms projected beyond the expected margin of the inferior vena cava without a definitive fat plane between the inferior vena cava wall and distal arm.4 of the lower legs perforated the inferior vena cava with the anterior limb extending 4mm into the anterior soft tissues abutting the gonadal vein without perforation.The left lateral legs perforate through the inferior vena cava wall into the aorta, extending 6mm beyond the inferior vena cava wall into the aorta.Therefore, the investigation is confirmed for positioning issue and perforation of 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 and in conjunction with or before orthopedic procedure.During deployment, the filter tilted and it was alleged that the filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.

• 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: 10533353
• MDR Text Key: 206916150
• Report Number: 2020394-2020-05636
• 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: 09/15/2020

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: GFPD4716
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/15/2020
• 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): Death
• Patient Age: 50 YR