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

Catalog Number RF320J

Device Problems Migration or Expulsion of Device (1395); Extrusion (2934); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Great Vessel Perforation (2152)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for migration and perforation as no objective evidence has been provided to confirm any alleged deficiency with the filter.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.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 the patient was injured when the filter migrated and perforated.The status of the patient is unknown.

Manufacturer Narrative

Manufacturing review: the device history record (dhr) could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images were not provided.Medical record was provided and reviewed.Approximately, ten years post filter deployment, ct revealed one of the posterior tines of the ivc filter appeared to have created a channel within the anterior/inferior aspect of the l4 vertebral body.This was unchanged across multiple prior studies.Therefore, the investigation is inconclusive for filter migration and perforation of the ivc.Based on the provided medical records, there is no clear evidence to confirm for perforation of the ivc as it reported that one of posterior tines of the filter appeared to have created a channel within the anterior/inferior aspect of the l4 vertebral body.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 patient injured when the filter migrated and perforated.The status of the patient is unknown.New information: 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 filter migrated and perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

Event Description

It was reported through the litigation process that patient injured when the filter migrated and perforated.The status of the patient is unknown.New information: 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 filter migrated and perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

Manufacturer Narrative

Manufacturing review: the device history record (dhr) could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images were not provided.Medical record was provided and reviewed.Approximately, ten years post filter deployment, ct revealed one of the posterior tines of the ivc filter appeared to have created a channel within the anterior/inferior aspect of the l4 vertebral body.This was unchanged across multiple prior studies.Therefore, the investigation is inconclusive for filter migration and perforation of the ivc.Based on the provided medical records, there is no clear evidence to confirm for perforation of the ivc as it reported that one of posterior tines of the filter appeared to have created a channel within the anterior/inferior aspect of the l4 vertebral body.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.

• Brand Name: G2 FILTER SYSTEM - JUGULAR
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7635330
• MDR Text Key: 112234549
• Report Number: 2020394-2018-00965
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K052578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF320J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOVENOX, COUMADIN; LOVENOX, COUMADIN
• Patient Outcome(s): Other
• Patient Weight: 61