MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER

Catalog Number UNKNOWN FILTER

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Cardiac Perforation (2513)

Event Date 04/02/2019

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.Approximately, twelve years seven months of post-deployment, computed tomography of the abdomen was revealed the filter was markedly tilted to the left (greater than 30 degrees).The retrieval tip abuts the inferior vena cava wall.The filter apex was approximately 2 cm below the most inferior renal vein.At least 7 struts perforate the inferior vena cava wall.The 2 struts with the greatest degree of perforation include a left anterior strut which extends approximately 2.5 cm beyond the inferior vena cava wall and traverses the aorta.A left posterior strut extends approximately 3.2 cm beyond the inferior vena cava wall and penetrates the adjacent vertebral body.The remaining struts had less than 2 cm of perforation.The tip of the filter was positioned at the level of the inferior endplate of l2.A severe tilt of 21 degrees to the right was present.The filter was severely deformed.There was a fractured and embolized arm in the chamber of the right ventricle.The 12 o'clock and 11 o'clock arms are within the inferior vena cava.There was grade 3 penetration of the 2 o'clock arm through the inferior vena cava 4 mm into the aorta.There was grade 3 penetration of the 4 o'clock arm through the inferior vena cava into the l3 vertebral body.There was grade 2 penetration of the 7 o'clock arm through the inferior vena cava into the retroperitoneum.There was one arm missing which was in the right ventricle.The 12 o'clock and 8 o'clock legs are in the inferior vena cava.There was grade 2 penetration of the 2 o'clock leg through the inferior vena cava into the retroperitoneum.There was grade 3 penetration of the 3 o'clock leg 1.5 cm into the aorta.There was grade 2 penetration of the 7 o'clock leg into the retroperitoneum.The sixth leg had fractured in two places, at its origin from the tip of the filter, and one-third of the way down the shaft of the leg.The proximal 1/3 of the leg was within the inferior vena cava lumen in a nearly horizontal orientation.The distal 2/3 of the leg demonstrates grade 3 penetration of 2.5 cm into the l3 vertebral body.Therefore, the investigation is confirmed for filter tilt, perforation of the inferior vena cava (ivc), filter limb detachment and material deformation.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.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 a vena cava filter was placed in a patient prior to gastric bypass surgery.At some time post filter deployment, it was alleged that filter detached, tilted and struts perforated outside the inferior vena cava with struts penetrating the aorta and l3 vertebral body.The device has not been removed and there were no reported attempts made to retrieve the filter.The detached struts retained in the right ventricle of the heart; however, the current status of the patient is unknown.

• Brand Name: VENA CAVA FILTER
• 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: 10903748
• MDR Text Key: 218229331
• Report Number: 2020394-2020-06443
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN FILTER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• 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
• Patient Age: 50 YR