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

Catalog Number RF310F

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Death (1802)

Event Date 05/03/2014

Event Type  Death  

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 review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately four years and four months post filter deployment, computed tomography (ct) revealed legs of the inferior vena cava filter was extending beyond the wall of the inferior vena cava.Eventually one year and nine months later, computed tomography (ct) pulmonary angiogram of the chest revealed there was small partial thrombus in the left in a first order left pulmonary artery extending toward the lingula.There also appeared to be linear thrombus on the right side extending into the right middle lobe.There were linear type thrombi identified in right lower lobe.Subsequently few days later, the patient was expired.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc).Additionally, it can be confirmed that the patient experienced pe post deployment.However, the relationship to the filter is unknown.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: 09/2012).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with right lower extremity deep venous thrombosis.Approximately four years and four months post filter deployment, it was alleged that the filter struts perforated and the patient was diagnosed with pulmonary embolism.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.

• 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: 10458523
• MDR Text Key: 204504217
• Report Number: 2020394-2020-05507
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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: GFTG2850
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• 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: CYCLOBENZAPRINE, DIAZEPAM, LISINOPRIL.; CYMBALTA, LIDODERM, AMLODIPINE, CLONIDINE.; HYDROMORPHONE, MORPHINE.; SIMVASTATIN, TRAZODONE, MIRALAX, DOCUSATE.
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 66 YR
• Patient Weight: 88