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

Catalog Number RF320J

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 07/21/2017

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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately eight months and thirty days later, computed tomography (ct) revealed that a filter was noted within the infra renal inferior vena cava.Approximately eight months and sixteen days later, the patient reported to the medical center with abdominal pain.On the same day, a computed tomography (ct) revealed that a bard inferior vena cava filter was in stable location, below the renal veins.No filter migration or bend/fracture was noted.The filter was tilted anteriorly with its cone lay near the wall of the inferior vena cava.Several of the arms and legs of the filter had penetrated through the inferior vena cava into the pericaval/mesenteric fat.One leg penetrated the duodenum.One leg penetrated the disc.Therefore, the investigation is confirmed for alleged 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.(expiry date:09/2011).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with morbid obesity and in conjunction with or before bariatric procedure.Approximately eight years and four months post filter deployment, a computed tomography (ct) abdomen and pelvis without intravenous contrast revealed that the filter tilted and filter struts perforated through the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.

• Brand Name: G2 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: 11075079
• MDR Text Key: 223705011
• Report Number: 2020394-2020-06505
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052578
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF320J
• Device Lot Number: GFSH2013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• 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: LIPITOR AND PROVENTIL; METFORMIN, GLIPIZIDE, JANUVIA AND GABAPENTIN; OMEPRAZOLE, PREDNISONE, TEMAZEPAM AND BACTRIM; PROZAC, GABAPENTIN, IBUPROFEN AND LISINOPRIL
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 113