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

Catalog Number RF310F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problem Abdominal Pain (1685)

Event Date 04/10/2009

Event Type  Injury  

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 struts perforated into organs.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

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, seven months of post deployment, computerized tomography pelvis with contrast showed an infra renal inferior vena cava filter was noted.A total of six of the struts have perforated the inferior vena cava.Two struts protruded anteriorly into the peritoneal space.The medial most strut projects towards the aorta with the tip situated adjacent to the aorta lumen; there was no evidence of perforation into the aorta.Posteromedially, there was a strut against the l3 vertebral body with adjacent periosteal reaction.The posterolateral strut terminates adjacent to the right iliopsoas muscle.After, fourteen days, inferior vena cava filter removal scheduled.Access gained via right internal jugular vein.After right ij access, 7f sheath inserted.Cone filter removal system advanced, multiple attempts made to capture the filter without success.Amplatz snare was the utilized, multiple attempts were made, unsuccessful.Final venogram using 4f right femoral vein access performed, showing patent filter, without large thrombus, and noted the head to be tilted and adherent to the lateral wall of inferior vena cava.Unsuccessful inferior vena cava filter removal attempt.Around one month and five days later, 2nd attempt at inferior vena cava filter removal was performed.Access was obtained in both the right internal jugular and femoral veins.Multiple different techniques including cone removal device, snares, balloon inflations to push filter off the wall, using forceps to try to move the filter were used but the inferior vena cava filter was unable to be retrieved.Of note was that some of the struts were dislodged from the vessel wall and the patient reported at that time and at the end of the case that pain was gone.Venography at the end of the case showed no extravasation of contrast and the filter remained in the same position.After, twenty-seven days, computerized tomography of the abdomen with and without contrast showed the patient's inferior vena cava filter was again demonstrated within the infrarenal inferior vena cava.There was no evidence for intraluminal thrombus.It remains in stable position with a few struts extending beyond the wall of the inferior vena cava.There has been no significant change from prior examination.Around, one month and six days later, lumbosacral spine three views showed that there was an inferior vena cava filter in place and one leg of the filter was projecting superiorly rather than inferiorly.However, the filter was in the same place when compared to prior exam and this leg was projecting superiorly at that time.Around, four months later, the patient presented with pain.Right foot x -ray three views showed that there was an inferior vena cava filter in place and one leg of the filter was projecting superiorly rather than inferiorly.However, the filter was in the same place when compared to prior exam and this leg was projecting superiorly at that time.Around, two months later, the patient has twice had attempted inferior vena cava removal, but it seems could not be removed.The patient was having nonspecific abdominal pain that was relieved with all the manipulation that was done trying to remove the filter.An inferior vena cava filter that could not be removed due to penetration of struts through the inferior vena cava.The patient pain has then resolved after the last retrieval.Around, five year seven months later, spine thoracic 2 views showed an inferior vena cava filter was present, projecting at the approximate level of l3-l4.Therefore, the investigation is confirmed for filter tilt, perforation of the inferior vena cava (ivc), material deformation, and retrieval difficulties.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 - 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12769569
• MDR Text Key: 280449412
• Report Number: 2020394-2021-80802
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CLONAZEPAM, WARFARIN, ARIPIPRAZOLE; COUMADIN, LOVENOX, SERTRALINE, HYDROXYZINE; CYCLOBENZAPRINE, HYDROCODONE, RANITIDINE; HYDROCHLOROTHIAZIDE, HYDROCODONE, IBUPROFEN; LISINOPRIL, MIRTAZAPINE, OMEPRAZOLE; POTASSIUM CHLORIDE, PRAVASTATIN, BUPROPION; SIMVASTATIN, WARFARIN, SIMVASTATIN, AND PREDNISONE
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White