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

Catalog Number RF400F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problem Abdominal Pain (1685)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary:the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately, eight years one month of post deployment, a computed tomography was performed, demonstrating presence of caval perforation and tilt.A grade 3 perforation of the 6 o'clock strut abutted the anterior right side of l3.Grade 2 perforation of the 7 o'clock strut was 0.53 cm.Grade 3 perforation of the 4 o'clock strut was 0.89 cm.Grade 2 perforation of the 12 o'clock strut was 0.36 cm and 11 o'clock strut was 0.39 cm.There was 12.19 degree coronal tilt and 15.95 degree sagittal tilt with the apex of the filter barely touched the right anterior wall of the inferior vena cava.Around, one month and three days later, a computed tomography abdomen and pelvis without contrast was performed, showing presence of properly positioning inferior vena cava filter.Around, one year six months later, another computed tomography was performed, identifying presence of inferior vena cava filter.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc) and filter tilt.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 perforated into the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient experienced abdominal pain; however, the current status of the patient is unknown.

• Brand Name: G2 X 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: 12292404
• MDR Text Key: 265542520
• Report Number: 2020394-2021-80690
• 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: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF400F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 59 YR