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

Catalog Number RF320J

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Extrusion (2934); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Death (1802); Great Vessel Perforation (2152)

Event Date 01/14/2008

Event Type  Death  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Medical records review: the patient status post bilateral femur fractures had an inferior vena cava filter deployed below the level of the renal veins.The filter was positioned appropriately and fully deployed.Final imaging demonstrated good position of the filter.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.There was no specific deficiency alleged in the provided medical records.Therefore, the investigation is inconclusive for tilted filter, retrieval difficulties, 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: the current ifu (instructions for use) states: warnings/potential complications: movement, migration or tilt of the filter are known complications of vena cava filters.Perforation or other acute or chronic damage of the ivc wall.Filter tilt.Filter malposition.Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.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 in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter tilted and filter limbs perforated through the caval wall.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The patient allegedly experienced sharp pains in the chest at the site of the filter.Approximately nine years post filter deployment, the patient expired; however, there was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death, the cause of the patient¿s death was not provided.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter tilted and filter limbs perforated through the caval wall.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The patient allegedly experienced sharp pains in the chest at the site of the filter.Approximately nine years post filter deployment, the patient expired; however, there was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death, the cause of the patient¿s death was not provided.

Manufacturer Narrative

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, four months later, the patient presented for filter removal, an access made via jugular vein, wire was advanced past the existed filter, and venogram revealed no clot in the filter, a g2 filter removal kit was introduced over the wire, and coned device used to grasp the filter.The filter had a significant degree of anterior angulation, with numerous legs protruded through the caval wall.Gentle pressure measured on the filter failed to disengage the legs, and it was determined that there was too high risk in continue with filter removal.Around, three years eight months later, computed tomography of the abdomen and pelvis was revealed the filter appeared to be penetration of the medial inferior vena cava by several filter struts.One strut appeared to pass in the vicinity of the posterior aorta.This may in fact be imbedded within the margin of the aortic wall.Two other struts appeared to be penetrated the wall of the inferior vena cava and seen within the retroperitoneal fat.Eventually, eleven days later, computed tomography of the abdomen and pelvis with and without contrast was revealed there was a protrusion of the filter through the wall of the inferior vena cava with at least three struts penetrated the wall.The filter was tilted toward the right.A single strut of the filter appeared to penetrate the wall of the posterior aorta though it was not definitely extended into the aortic lumen.This did not definitely enter the aortic lumen.Subsequently, five months later, a computed tomography angiogram of the abdomen with and without contrast was revealed the filter superior portion directed to the right and extended beyond the vessel lumen.At least 3 struts extended medially from the vessel lumen toward the aorta and are either located in close approximation to the posterior wall of the aorta or possibly embedded within the posterior wall.Around nine months later, computed tomography of the abdomen and pelvis with and without contrast revealed the filter was unchanged in position with margins penetrated beyond the wall of the inferior vena cava.The patient experienced left quadrant abdominal pain.The filter eroded through the inferior vena cava and attached to the aorta.Therefore, the investigation is confirmed for filter tilt, perforation of the inferior vena cava (ivc), and retrieval difficulties.Per medical records, coned device used to grasp the filter but were unsuccessful due to filter tilt and perforation of the inferior vena cava, this could have contributed to the retrieval difficulties.However, 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 current ifu (instructions for use) states: warnings: - movement, migration or tilt of the filter are known complications of vena cava filters.Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.Potential complications: movement, migration or tilt of the filter are known complications of vena cava filters.Perforation or other acute or chronic damage of the ivc wall.Filter tilt.Filter malposition.

• 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: 7381679
• MDR Text Key: 103827651
• Report Number: 2020394-2018-00301
• 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
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• 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: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 67 YR