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

Catalog Number RF310F

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pulmonary Embolism (1498)

Event Date 08/09/2009

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.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.Bard filter was implanted at junction for a patient with the history of pulmonary embolism and the filter was migrated cephalad during deployment.Approximately one year eleven months later, left lower extremity venous duplex revealed that there was no obvious deep vein thrombosis.Approximately one year later, the patient presented with chest pain and shortness of breath.Subsequent computerized tomography(ct) revealed that pulmonary emboli in the left lower lung and also filling defects within the branch arteries of the proximal left pulmonary arteries.Therefore, the investigation is confirmed for migration of filter and pulmonary embolism (pe) post implant.Based on 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: 05/2012).

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 migrated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with 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: 10238236
• MDR Text Key: 197732997
• Report Number: 2020394-2020-04310
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• 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: GFTB3627
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2009
• 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: LOVENOX, COUMADIN
• Patient Outcome(s): Life Threatening
• Patient Age: 47 YR