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

Catalog Number RF048F

Device Problems Obstruction of Flow (2423); Detachment of Device or Device Component (2907)

Patient Problem Pulmonary Embolism (1498)

Event Date 03/11/2013

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation; however, medical records were provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported through the litigation process that a vena cava filter was deployed successfully, after being diagnosed with bilateral lower extremity swelling with venostasis disease and prior to major abdominal surgery.Approximately nine years ten months post filter deployment, lumbar spine anteroposterior, lateral, and coned-down lateral lumbosacral spine views was performed, it alleged that the filter struts detached.The device has not been removed after an unsuccessful percutaneous removal procedure.The patient reportedly diagnosed with pulmonary embolism post filter implant; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, five years post filter deployment, retrieval of the filter was scheduled.Inferior vena cavogram demonstrated occlusion of the inferior vena cava extending from the superior point of the filter distally.Numerous venous collaterals were seen filling into the remaining portion of the infrarenal vena cava.Filter retrieval attempt was abandoned due to the extensive tissue involvement with the filter.Approximately four years later, computed tomography revealed a small embolus within the segmental artery of the right lower lobe which had propagated more distally now and was probably mildly decreased in size.Approximately one year later, lumbar spine anteroposterior, lateral, and coned-down lateral lumbosacral spine views were performed, and the inferior vena cava filter was present.There was fracture of one of the inferior vena cava inferior vena cava legs on the right side.Position of the inferior vena cava filter appeared unchanged from previous study.Therefore, the investigation is confirmed for occlusion of the ivc filter and filter limb detachment.Additionally, it can be confirmed that the patient experienced pulmonary embolism post deployment.However, the relationship to the filter is unknown.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.H10: d4(expiration date: 02/2007), g4.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.

Event Description

It was reported through the litigation process that a vena cava filter was deployed successfully, after being diagnosed with bilateral lower extremity swelling with venostasis disease and prior to major abdominal surgery.Approximately nine years and ten months post filter deployment, lumbar spine anteroposterior, lateral, and coned-down lateral lumbosacral spine views was performed, it alleged that the filter struts detached.The device has not been removed after an unsuccessful percutaneous removal procedure.The patient reportedly diagnosed with pulmonary embolism post filter implant; 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: 10585082
• MDR Text Key: 208497696
• Report Number: 2020394-2020-05808
• 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
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• 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: GFOB3485
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 43 YR