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

Catalog Number RF310F

Device Problems Malposition of Device (2616); Extrusion (2934); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2017

Event Type  malfunction  

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 tilt and perforation of the ivc 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 sometime post vena cava filter deployment the filter tilted and perforated the inferior vena cava in multiple locations.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.

Event Description

It was reported through the litigation process that sometime post vena cava filter deployment the filter tilted and perforated the inferior vena cava in multiple locations.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.

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 tilt and perforation of the ivc 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.H11:section a through f - 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.

Manufacturer Narrative

H10: manufacturing review: a 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, five years eleven months of post deployment, computed tomography of the abdomen without contrast was revealed the filter was present at the level of l3, below the renal veins.The filter was angled anteriorly and to the right.At least 3 of the struts appeared to be migrated beyond the wall of the vena cava.Therefore, the investigation is confirmed for filter tilt.Based on the provided medical records, there is no clear evidence to confirm for perforation of the inferior vena cava (ivc) as it was reported as " at least 3 of the struts appeared to be migrated beyond the wall of the vena cava." 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.H11:section a through f - the information provided by bd 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 bd.

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 tilted and perforated the inferior vena cava in multiple locations.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.

• Brand Name: G2 FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7659975
• MDR Text Key: 113074879
• Report Number: 2020394-2018-01091
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K062887
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF310F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 07/17/2018; 11/11/2020
• Supplement Dates FDA Received: 08/09/2018; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN, AND HYDROCORTISONE
• Patient Age: 49 YR