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

Catalog Number RF048F

Device Problems Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913); Extrusion (2934); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Perforation (2001)

Event Date 03/29/2010

Event Type  Injury  

Manufacturer Narrative

No device or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The investigation of the reported event is currently underway.Medical records were received and reviewed.Patient had a vena cava filter deployed successfully for protection of dvt and pe.A ct scan performed five years post vena cava filter deployment demonstrated four filter limbs perforated the ivc wall.Based on medical records received, no attempts were made to retrieve the vena cava filter.The information provided by bard 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 bard.

Event Description

It was reported that approximately five years post vena cava filter deployment for protection of dvt and pe for a surgical procedure; a ct scan demonstrated four filter limbs perforating the ivc wall.Based on the medical records provided, no attempt was made to retrieve the vena cava filter.Patient was reported to be asymptomatic.

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Image/photo review:no medical images have been made available to the manufacturer.Conclusion: the device was not returned.Medical records were provided.The medical records allege a ct scan demonstrated four filter limbs perforating the ivc wall.The patient was reportedly asymptomatic.Based on the medical records, the investigation is confirmed for perforation of the ivc.Based upon the available information, the definitive root cause for filter perforation is unknown.It is unknown if patient or procedural factors contributed to the reported event.Labeling review: the current ifu (instructions for use) states: - potential complications: perforation or other acute or chronic damage of the ivc.The information provided by bard 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 bard.

Manufacturer Narrative

H10: manufacturing review: a device history review (dhr) 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 after five years a computed tomography shows that extension of filter legs outside of the inferior vena cava with one leg inciting a reactive change in the adjacent vertebra l3.Two legs contact the adjacent duodenum.One leg contacts the posterolateral margin of the aorta.Approximately after another six years a computed tomography shows most cephalad tip at the level of the l2-l3 disc level.The length of this inferior vena cava filter penetrates the wall and extends outside of the inferior vena cava.There was a posterior ligamentous inferior vena cava which appears broken and deflected in a cephalad direction, a magnetic resonance imaging (mri) and inferior vena cava filter had dislodged in four different areas.Therefore, the investigation is confirmed for perforation of the ivc filter and filter limb detachment.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.The current instructions for use states: potential complications: - perforation or other acute or chronic damage of the ivc.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient prior to undergoing a hysterectomy, history of factor v leiden mutation and for the protection of deep vein thrombosis and pulmonary embolism for a surgical procedure.Approximately five years, post filter deployment, a computed tomography scan demonstrated that the filter struts extending outside the inferior vena cava and in contact with the adjacent duodenum, aorta, and spine.Approximately eleven years post filter deployment, a computed tomography scan demonstrated that the posterior limb has detached from the filter and the struts continued to penetrate the wall of the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced back pain; however, 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
• MDR Report Key: 5198242
• MDR Text Key: 30514149
• Report Number: 2020394-2015-01793
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K031328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• 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
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN; COUMADIN; OXYCODONE AND HYDROCODONE
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 106