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

Catalog Number RF048F

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 04/13/2010

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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately, two years three months of post deployment, the patient presented with lower back pain.Around, six months and six days later, the patient presented with abdominal pain.On the same day, a computed tomography (ct) abdomen and pelvis with intravenous contrast showed an inferior vena cava filter was present.Around, six months and four days later, a computed tomography (ct) abdomen and pelvis with intravenous contrast showed that an inferior vena cava filter was in place.Around, one year and twenty-two days later, an ultrasound duplex extremity venous lower right showed that there was an inferior vena cava filter in place.Around, eleven months and twenty-four days later, an x-ray abdomen showed that there was a bard recovery inferior vena cava filter based on the metallic tip on the cone and the configuration of the short struts.The inferior vena cava filter was seen in the inferior vena cava at the tip of l2-l3.Two of the shorter legs (struts) of the inferior vena cava filter had fractured and were located in the retroperitoneum either within the soft tissues or small retroperitoneal veins.One of the longer legs of the inferior vena cava filter was deflected superiorly with penetration through the inferior vena cava.Two of the shorter legs of the inferior vena cava filter were deflected superiorly rather than inferiorly.All legs of the inferior vena cava filter were accounted for in the abdominal imaging.No migration into the chest was noted.Around, two years and eight months later, an x-ray abdomen showed that a vena cava filter was noted at the level of l3.Around, one year seven months later, a computed tomography angiography (cta) chest with and without intravenous contrast showed no pulmonary embolism.Around, one year and ten months later, a computed tomography angiography (cta) abdomen and pelvis with and without intravenous contrast showed that the inferior vena cava below the filter was occluded.The inferior vena cava filter was collapsed.There were 2 struts on the right within the soft tissues.One strut was located between the second portion of the duodenum and the ureteropelvic junction of the right kidney.The second metallic strut was located posterior to the proximal right ureter.A third strut remained in contact with the filter and extended into a paravertebral venous collateral.The remainder of the struts, as mentioned previously, collapsed upon themselves.The struts did not enter a vital organ or structure.Therefore, the investigation is confirmed filter limb detachment, perforation of the inferior vena cava (ivc) and material deformation.However, the investigation is inconclusive for filter tilt.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 a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter tilted, struts detached and collapsed.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: RECOVERY FILTER SYSTEM
• 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: 12180586
• MDR Text Key: 261933401
• Report Number: 2020394-2021-80570
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031328
• 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: 07/16/2021

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: RF048F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/16/2021
• 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: COUMADIN, BACLOFEN, ENABLEX AND LEXAPRO; SENNA, CELEXA AND TYLENOL
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 82