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

Catalog Number RF320J

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Post-deployment, it was noted that an inferior vena cava filter was migrated, which could have been the cause of abdominal pain.Approximately, three years and ten months later, the patient was admitted to the hospital with abdominal pain and the prongs of the inferior vena cava filter was penetrated the inferior vena cava wall and also a small bowel.Filter removal procedure was performed.Under ultrasound guidance, the right internal jugular vein was accessed with an 18-gauge needle.A guidewire was passed.A 5-french was placed, and a hard copy was saved.Under ultrasound guidance, the right common femoral vein was identified and accessed with an 18-gauge needle.A guidewire was passed.A 5-french sheath was introduced.Then, the omni flush catheter was placed in the right femoral vein, right femoral venogram was performed, and then the catheter was placed in the inferior vena cava and inferior venacavogram was performed.The right jugular sheath was exchanged with a 12-french filter removal system.Then a snare was passed and was able to grasp the hook of the snare and the filter was removed by advanced the sheath.The filter was in the sheath and it was taken out completely.After removal of inferior vena cava filter, there was no evidence of extravasation or thrombus.From the previous study, it was reported that an inferior vena cava filter was unchanged which demonstrated that one limb extended behind the abdominal aorta, possibly into a lumbar vein.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc) and filter migration.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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in conjunction with or before bariatric procedure.At some time post filter deployment, it was alleged that the filter migrated and struts perforated.The device was removed percutaneously.The patient reportedly experienced abdominal pain; however, the current status of the patent 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: 10955650
• MDR Text Key: 219881466
• Report Number: 2020394-2020-06475
• 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: 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• 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
• Patient Outcome(s): Other