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

Catalog Number RF400J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Embolism (1498)

Event Date 06/06/2009

Event Type  Death  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.Medical records were not provided.There were no device deficiencies identified within the medical records.The patient reportedly expired.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Additionally, it can be confirmed that the patient experienced pulmonary embolism post deployment.However, the relationship to the filter is unknown.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Expiry date: 04/2012.

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 patient reportedly expired due to acute pulmonary embolism post implant.The device has not been removed and there were no reported attempts made to retrieve the filter.

• Brand Name: G2 X FILTER SYSTEM - JUGULAR
• 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: 11862046
• MDR Text Key: 251887761
• Report Number: 2020394-2021-01088
• 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: 05/06/2021

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: RF400J
• Device Lot Number: GFTC2585
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/21/2021
• 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: COUMADIN
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 37 YR