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

Catalog Number RF400J

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 04/20/2014

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 review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately three years and two months post filter deployment, patient presented with abdominal pain.Approximately three years later, computed tomography revealed the superior central core of the filter lies just inferior to the left renal vein, which was the most inferior of the two veins.The core was aligned straight with the longitudinal access of the inferior vena cava.The struts in general pierce the outer wall of the inferior vena cava.One of the struts at approximately 2 o'clock extends anterior laterally towards the left and pass through anterior right edge of the aortic wall and terminates in the anterior central aortic wall.The strut posterior to that extends laterally at approximately 3 o'clock to 4 o'clock and terminates outside the aorta 0.9 cm to the left of the inferior vena cava.The other struts extend outside the confines of the inferior vena cava for 0.3 cm to 0.4 cm each.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).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: 11/2012).

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 filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• 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 NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11384891
• MDR Text Key: 233740637
• Report Number: 2020394-2021-80208
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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: GFTJ1955
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2021
• 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: ALBUTEROL, LOPRESSOR, NITROGLYCERIN, GENTAMYCIN; CARVEDILOL, MONTELUKAST, ROSUVASTATIN, TOPIRAMATE; CIPRO, XARELTO, PROVENTIL, EPIPEN, TOPAMAX; CRESTOR, ERGOCALCIFEROL, COUMADIN, TOPIRAMATE,; DILAUDID, DEPAKOTE, BENADRYL, FIORICET, ASPIRIN; FLAGYL, LORTAB; LISINOPRIL, CLARITIN, SUMATRIPTAN SUCCINATE; OMEPRAZOLE, ELIQUIS, FEXOFENADINE, ALLEGRA; ROBAXIN, NORETHINDRONE, LEVAQUIN, EPINEPHRINE; SINGULAIR, LOVENOX, VICODIN, MOTRIN, IMITREX
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 125