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); Patient Device Interaction Problem (4001)

Patient Problem Chest Pain (1776)

Event Date 12/23/2004

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.The investigation of the reported event is currently underway.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient for clot due to a breathing problem.At some time post filter deployment, it was alleged that the filter struts detached and perforated.The device was removed percutaneously.Reportedly one detached strut migrated to heart and located at right lateral inferior vena cava; renal vein and right ventricle, near the pericardial surface.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 months twenty-eight days of post-deployment, through right internal jugular vein access under fluoroscopic visualization, the cone of the inferior vena cava filter retrieval device was placed directly over the apex of the filter.The filter was removed in its entirety from the patient.Prior to retrieval of filter, the strut overlying the lateral aspect of the right l1 vertebral body appeared to be continuous with the right renal vein.That remained in the patient.No attempt to snare this metallic density was performed in view of possible endothelialization of the density.Eventually, one month later, the patient was admitted to the hospital because of chest pain.After the filter removal, two pieces of it became dislodged and one of them was stuck in the pulmonary artery.Around, twelve years and seven months later, computed tomography (ct) abdomen with contrast, computed tomography (ct) 3d reconstruction, and computed tomography (ct) thorax with contrast were performed.A fragment of the radio dense strut was present in the right ventricle, close to the pericardial surface.Therefore, the investigation is confirmed for filter limb detachment, however, the investigation is inconclusive for the perforation of the inferior vena cava (ivc).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.H10: d4(expiration date: 05/2006).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 placed in a patient for clot due to a breathing problem.At some time post filter deployment, it was alleged that the filter struts detached and perforated.The device was removed percutaneously.Reportedly one detached strut migrated to heart and located at right lateral inferior vena cava; renal vein and right ventricle, near the pericardial surface.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: 10688681
• MDR Text Key: 211628395
• Report Number: 2020394-2020-05972
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• 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: 07DN3658
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MAVIK, HYDROCHLOROTHIAZIDE; MAVIK, HYDROCHLOROTHIAZIDE; MAVIK, HYDROCHLOROTHIAZIDE
• Patient Outcome(s): Other
• Patient Age: 58 YR