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

Catalog Number RF310F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Chest Pain (1776)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

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 filter detached, tilted and perforated.The device and the detached struts was removed via an open abdominal procedure.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: a sample evaluation could not be performed as the device was not returned.Medical records were provided and reviewed.Approximately eight years and one month post filter deployment, patient presented with abdominal pain.Subsequently, undergone imaging which revealed a mal-positioned inferior vena cava filter.Unfortunately, the stent was never retrieved, and the patient presented several months ago with intermittent pleuritic chest pain bilaterally.This was associated with some shortness of breath.Chest x-ray leading to computerized tomography scan showed 2 struts, which had been fractured and embolized into pulmonary arteries.Then went for open inferior vena cava filter retrieval.The patient had exposure of the retroperitoneum and isolation of the distal aorta and the inferior vena cava.Snares were placed around the common iliac veins bilaterally.Snares were placed around the common iliac veins bilaterally.There was a strut from the stent going into the distal aorta and the proximal left common iliac artery.There was another strut from the stent going into the prevertebral fascia.There was another strut from the stent, which was external to the inferior vena cava on the anterior wall of the inferior vena cava.There was another strut from the stent proximally near the nose cone of the stent, which was protrusive off the right lateral aspect of the stent.In this same area, the nose cone of the filter had protruded through the inferior vena cava and was outside the inferior vena cava as well and covered by a large fibrous scar tissue.Then removed the protruding struts that were in the distal aorta and in the proximal left common iliac artery after that had placed purse string stitches around them and tied them down.Then made a longitudinal venotomy in the inferior vena cava, which extended from the proximal right common iliac vein all the way up the inferior vena cava past the tip of the nose cone.The entire filter was now removed making a small hole about 2mm in the right lateral surface of the aorta with the nose cone and the retrieving hook had protruded outside of the vessel.Gross description consists of a grossly identifiable inferior vena cava filter measuring 4.6 cm in length with multiple metal segments protruding out from one direction with two portions of red-tan soft tissue.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter limb detachment.However, the investigation is inconclusive for filter tilt.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 in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that filter detached, tilted and perforated.The device and the detached struts were removed via an open abdominal procedure.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: 11347015
• MDR Text Key: 232521923
• Report Number: 2020394-2021-80177
• 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
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN, VANCOMYCIN, ZINACEF, ZOFRAN, ONDANSETRON; COUMADIN, VANCOMYCIN, ZINACEF, ZOFRAN, ONDANSETRON; ESCITALOPRAM, HYDROXYZINE HCI, OLANZAPINE; ESCITALOPRAM, HYDROXYZINE HCI, OLANZAPINE; HYDROCODONE-ACETAMINOPHEN, TRAZODONE HCL; HYDROCODONE-ACETAMINOPHEN, TRAZODONE HCL; METHOCARBAMOL, DALTEPARIN, CALCIUM CARBAMOL; METHOCARBAMOL, DALTEPARIN, CALCIUM CARBAMOL; PRAZOSIN, DIPHENHYDRAMINE; PRAZOSIN, DIPHENHYDRAMINE; PROTAMINE SULFATE; PROTAMINE SULFATE; COUMADIN, VANCOMYCIN, ZINACEF, ZOFRAN, ONDANSETRON.; ESCITALOPRAM, HYDROXYZINE HCI, OLANZAPINE.; HYDROCODONE-ACETAMINOPHEN, TRAZODONE HCL.; METHOCARBAMOL, DALTEPARIN, CALCIUM CARBAMOL.; PRAZOSIN, DIPHENHYDRAMINE.; PROTAMINE SULFATE.
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 29 YR
• Patient Weight: 64