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 Interaction Problem (4001)

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

Event Date 08/19/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history record (dhr) 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 six years and eight months post filter deployment, patient presented with abdominal pain, flank pain and an ivc filter was poking through the vein walls.A day later, ct revealed an ivc filter was tilted with many of the limbs of the filter projecting beyond the walls of the ivc.Some of the limbs project into the region of the aorta as well as into the anterior aspect of the l3-l4 disc space.Eventually a month later, patient presented with abdominal pain.Subsequent ct revealed, filter tines are again noted to extend beyond the borders of the ivc, containing the anterior aspect of the vertebral column and the aorta.Therefore, the investigation is confirmed for the perforation of the ivc.However, the investigation is inconclusive for filter tilt and pe post implant.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.

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 embedded in the wall of ivc and struts perforated into retro aortic left renal vein invading the l3-l4 space.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced severe abdominal, back and side pain and also experienced pulmonary embolism; however, 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
• 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: 9486240
• MDR Text Key: 174561289
• Report Number: 2020394-2019-05676
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• 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: 12/13/2019
• 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
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 39 YR