MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 EXPRESS FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number RF400F

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Extrusion (2934)

Patient Problem Great Vessel Perforation (2152)

Event Date 06/18/2011

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Medical records review: the patient with history of pulmonary emboli status post trauma had a vena cava filter deployed in an infrarenal location without incident.Approximately four years ten months post filter deployment, lumbar spine x-ray demonstrated a malpositioned inferior vena caval filter in place which did not appear changed from a previous ct examination performed approximately two years post filter deployment, at which time struts from the filter were shown to extending outside the lumen of the cava, abutting the aorta.Investigation summary: the device was not returned and images were not provided for review.However, medical records were provided and reviewed.Based on the provided medical records, the investigation can be confirmed for a malpositioned filter with filter limbs perforating the ivc wall.The investigation is inconclusive for the alleged migration and filter limb detachment.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: movement, migration or tilt of the filter are known complications of vena cava filters.Migration of filters to the heart or lungs has been reported.Filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.Perforation or other acute or chronic damage of the ivc wall.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

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, perforated into organ(s), and migrated to the heart.The status of the patient is unknown.

• Brand Name: G2 EXPRESS FILTER SYSTEM - FEMORAL
• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7299417
• MDR Text Key: 101056434
• Report Number: 2020394-2018-00160
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2011
• Device Catalogue Number: RF400F
• Device Lot Number: GFSC1066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2008
• 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: LOVENOX, COUMADIN
• Patient Outcome(s): Life Threatening
• Patient Age: 26 YR