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); Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Chest Pain (1776); Cardiac Perforation (2513)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for filter migration, perforation of the inferior vena cava (ivc)and filter limb detachment as no objective evidence has been provided to confirm any alleged deficiency with the filter.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 the filter migrated through the inferior vena cava and the detached limb perforated the right ventricle.The current status of the patient is unknown.

Event Description

It was reported through the litigation process that the filter migrated through the inferior vena cava and the detached limb perforated the right ventricle.The current status of the patient is unknown.

Manufacturer Narrative

H10: 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.Approximately eight years and three months later, right ventricular perforation repair was done through sternotomy.After three weeks, an inferior vena cavogram was performed which showed an indwelling inferior vena cava filter with fractured limb in the right ventricle.Inferior vena cava filter removal was also attempted on the same date, through right internal jugular vein, the catheter was positioned below the inferior vena cava filter.A 30 mm gooseneck snare was used to retrieve the filter.A snare was placed within the right atrium as an attempt to remove the foreign body which was not successful.A right common femoral venous access was attempted to remove the filter.At this point due to high radiation dose and in ability to snare the filter the procedure was terminated.The filter was found to be significantly tilted and only has 11 of 12 limbs.The filter was found with minimal luminal thrombus.The right atrial fracture filter limb does not appear to be intraluminal and is likely within the myocardium.The patient will likely require endovascular laser assisted removal of the inferior vena cava filter.On the next day, patient reported to the hospital with complaints of chest pain.During examination, cardiology determined that the original cause of perforation was a piece of inferior vena cava filter that had broken off and migrated to her right ventricle.After five days, recent hospitalization for coronary vein perforation repair revealed a foreign object present.It was suspected to be a migrated piece of inferior vena cava filter perforating right ventricle.Laser assisted inferior vena cava filter removal was planned by the physician.After three weeks, the patient had undergone a left heart catheterization for non-st-segment elevation myocardial infarction which developed pericardial effusion and tamponade thereafter.She also had undergone thoracotomy, exploration and was found to have a coronary sinus perforation which was likely secondary to a broken tine from her inferior vena cava filter.The perforation was repaired.Following surgery she made good recovery.Thereafter attempts were made to remove the inferior vena cava filter as well as the tine which was embedded in her right ventricle muscle but were unsuccessful.After one month, it was found that the filter was tilted.Additionally, at least one of the legs projects outside of the lumen of the inferior vena cava filter.In fact, one of the leg limbs is directed cephalad.An 18 french sheath was used to remove the inferior vena cava filter made the filter to collapse allowing the filter to be pulled into the sheath.The filter was successfully removed.Therefore, the investigation is confirmed for the alleged filter migration, perforation of the inferior vena cava, filter tilt, material deformation, filter detachment and retrieval difficulties.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.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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: 10118142
• MDR Text Key: 193927734
• Report Number: 2020394-2020-03626
• 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: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• 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: 10/29/2021
• 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: DILTIAZEM, SOTALOL AND NEXIUM
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 137 KG
• Patient Race: White