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); Material Deformation (2976)

Patient Problem Pain (1994)

Event Date 12/05/2019

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 right sided pulmonary emboli.Approximately eleven years and eight months post filter deployment, it was alleged that the filter tilted, struts perforated into organs, struts bent, and the patient reportedly experienced abdominal pain and back pain.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 records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately one year and nine months later post filter deployment, the patient complained of chronic lower back pain.After two years, the patient complained to have significant and continuous abdominal pain.A computed tomography of abdomen and pelvis was performed for abdominal pain on the same day.The study showed that an inferior vena cava filter was noted with its superior most tip just below the level of the renal veins.After five days, a computed tomography of abdomen and pelvis was performed for right lower quadrant pain and the study showed an inferior vena cava filter was in place.After seven years and ten months, a computed tomography of abdomen and pelvis was performed for evaluation of inferior vena cava filter and unspecified injury of inferior vena cava.The study showed that an inferior vena cava filter was present in the infrarenal portion of the inferior vena cava.Significant tilt was seen with respect to the inferior vena cava and the apex of the filter does not come in contact with the wall of the inferior vena cava.Also, no fracture of the struts was seen.The study also showed that the struts of the filter projected beyond the walls of the inferior vena cava as follows: right anterior strut, 5.4mm; left anterior strut, 6.5mm and this strut abutted the right lateral wall of the aorta but does not penetrated it; left lateral strut, 2.3mm; left posterior strut, 3.8mm and this strut abutted the right anterolateral aspect of the superior endplate of l5; right posterior strut, 3.1mm and the right lateral strut, 3.9mm.Also, the left posterior strut and the right posterior strut were adjacent to each other, indicated that they may not have fully deployed.Therefore, the investigation is confirmed for the alleged filter tilt, perforation of the inferior vena cava and material deformation.A definitive root cause could not be determined based upon available information based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 02/2011).

• 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 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14332443
• MDR Text Key: 291354062
• Report Number: 2020394-2022-00355
• 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: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2022

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: GFSA3565
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2022
• Initial Date FDA Received: 05/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2008
• 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: DEXAMETHASONE, COUMADIN AND ZERIT; PERCOCET AND MORPHINE
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White