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

Catalog Number RF320J

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Injury (2348); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing review:the device history record (dhr) 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 the alleged perforation of the ivc as no objective evidence has been provided to confirm any alleged deficiency with the filter.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 one of the filter struts perforated the aorta and the patient underwent an open laparotomy surgery to have the filter removed; however the current status of the patient is unknown.

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 eleven years post filter deployment, computed tomography revealed positive for caval perforation.Superior extent of the inferior vena cava filter at l3-l4 disc and inferior extent superior l5 vertebral body.A total of 7 prongs have perforated the inferior vena cava and maximum distance prongs perforated 7 mm.Approximately five months later, surveillance imaging for the aneurysm has demonstrated the incidental findings of multiple strut perforations of the inferior vena cava, including one strut that has also penetrated the adjacent infrarenal aorta.Patient was scheduled for filter retrieval.Sharp dissection was used to expose the struts perforating the abdominal aorta which was cut with a wire cutter and manually removed without the need for an infrarenal aortic cross-clamp.Then cross clamped the inferior vena cava on either side of the palpable vena cava filter.Noted ongoing filling of the vena cava which improves with application of a second clamp superior to the filter.The filter was visualized within the lumen of the vena cava but was densely adherent and its tip seemed incorporated in the posterior vena caval wall.Wire cutters were used to remove several additional struts penetrating the posterior wall and right sided wall of the vena cava.Scissors were then used to excise the vena cava filter from within the lumen and it was passed off the field as a specimen the pathology along with the struts of the been removed piecemeal.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.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.

Event Description

It was reported through the litigation process that one of the filter struts perforated the aorta and the patient underwent an open laparotomy surgery to have the filter removed; 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
• MDR Report Key: 9932528
• MDR Text Key: 186680828
• Report Number: 2020394-2020-02444
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K052578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/07/2020
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR