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

Catalog Number RF310F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately thirteen days post ivc filter placement, through the left femoral vein approach, a vena cava filter sheath was passed through the inferior vena cava filter and subsequently a cook, tulip filter was placed in the superior vena cava, with the apex pointed toward the right atrium.A post placement cavogram was performed with the filter found to be in good position.The inferior vena cava filter was unchanged in position throughout the procedure and at the conclusion of the procedure.Around twelve years and two months later, a computed tomography of abdomen showed that the apex of the filter touches the anterior wall of the inferior vena cava indicating right anterolateral tilt.The apex of the filter is 1.2 cm distal to the lowest renal vein, the right satisfactorily.There is right anterolateral perforation through the inferior vena cava wall approximating the second portion of the duodenum, there is left posterior lateral perforation into the prevertebral space.There is posterior perforation also into the prevertebral space.There is right posterior lateral perforation approximating the psoas muscle.There is anterior perforation approximating the right common iliac artery.There is left lateral perforation adjacent to the aorta.There is significant bending of several struts projecting to the left into the prevertebral soft tissues and posterior into the prevertebral soft tissues.There is minimal bending of the distal margins of the struts projecting through the inferior vena cava wall caudally.No structural fracture was seen.Therefore, the investigation is confirmed for the reported perforation of inferior vena cava, filter tilt and filter strut bent.Based on the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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.H3 other text : device not returned.

Event Description

It was reported through the litigation process that an inferior vena cava filter was placed in a patient via the right femoral vein approach after being diagnosed with trauma with multiple injuries.Twelve years, three months, and seven days post filter deployment, it was alleged that the filter strut had perforated the right anterolateral through the inferior vena cava wall approximating the second portion of the duodenum, there was left posterior lateral perforation into the prevertebral space, there was posterior perforation also into the prevertebral space, there was right posterior lateral perforation approximating the psoas muscle, there was anterior perforation approximating the right common iliac artery, and there was left lateral perforation adjacent to the aorta, and there was significant bent of filter struts projected to the left into the prevertebral soft tissues and posterior into the prevertebral soft tissues, and there was minimal bent of the distal margins of the struts projected through the inferior vena cava wall caudally, and the filter apex had touched the anterior wall of the inferior vena cava indicating right anterolateral tilt.However, the device has not been removed and there were no reported attempts made to retrieve the filter.There was no reported patient injury.

• Brand Name: G2 FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18343113
• MDR Text Key: 330660086
• Report Number: 2020394-2023-01277
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF310F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2023
• 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 Age: 41 YR
• Patient Sex: Male