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

Catalog Number RF400F

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

Patient Problems Abdominal Pain (1685); Thrombus (2101)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately 20 days later, venous duplex exam was performed, a small focal area of recanalized chronic venous thrombus was identified in the right peritoneal vein.After 4 weeks, computed tomography (ct) guided drain placement was done and an ivc filter was noted.After 6 months and 2 weeks, pet computed tomography (ct) was performed, and the inferior vena cava filter was noted in the infrarenal inferior vena cava.After 6 years and 5 months, the patient came to follow up with the complaint of having an abdominal pain off and on since her surgery and having pain in the left lower quadrant.After 4 days, a computed tomography (ct) angiography abdomen was performed, the inferior vena cava filter was present with its tip at the anatomic axial plane of the mid-l3 lumbar vertebral body.Two of the filter prongs at the right lateral aspect of the filter site were probably outside the caval lumen.There were two other filter prongs that were possibly outside the caval wall.On delayed images, a small amount of thrombus within the cava just above the filter.The inferior vena cava at the level of the filter tip was mildly narrowed.After 10 weeks, through right jugular vein access, an inferior filter was removed successfully.Vena cava gram was taken, a small section of the strut which was along with one of the long-embedded implantation struts was clearly and embedded in the right lateral vena cava wall.There were no options for removing this and it was reported as not safe to try.Therefore, the investigation is confirmed for alleged filter limb detachment.However, the investigation is inconclusive for filter tilt and perforation of the ivc.Based on the provided medical record there is no objective evidence to confirm for perforation of the ivc as it states ¿ two of the filter prongs at the right lateral aspect of the filter site were probably outside the caval lumen.There were two other filter prongs that were possibly outside the caval wall.¿ additionally, it can be confirmed that the patient experienced thrombus above the filter post-deployment.However, the relationship to the filter is unknown.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.(expiry date: 07/2012).

Event Description

It was reported that approximately seven years and four months post filter deployment, a ct angiography revealed that the filter struts perforated the inferior vena cava wall and the detached struts embedded in the vena caval wall.It was further reported that seven years and five months later the device was removed.The patient was diagnosed with thrombus above the filter and reportedly experienced abdominal pain primarily in the lower left quadrant; however, the current status of the patient is unknown.New information: 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 and due to blood clot.At some time post filter deployment, it was alleged that the filter tilted, detached and perforated.The device was removed percutaneously.The detached strut retained in right lateral vena cava wall.The patient reportedly experienced severe intermittent abdominal pain; however, the current status of the patient is unknown.

• Brand Name: G2 X 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: 10104759
• MDR Text Key: 193022367
• Report Number: 2020394-2020-03556
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082305
• 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: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF400F
• Device Lot Number: GFTF3715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• 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: ATIVAN, LORTAB, MOTRIN; HYDROCODONE-ACETAMINOPHEN, LOVENOX; SULFATRIM, COUMADIN
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 48