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

Catalog Number RF048F

Device Problems Obstruction of Flow (2423); Malposition of Device (2616); Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problem Pulmonary Embolism (1498)

Event Date 06/20/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the 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 eleven years and three months of post deployment, the patient was diagnosed with pulmonary embolus, computed tomography angiogram of chest and computed tomography of abdomen and pelvis with contrast was performed which revealed there was an inferior vena caval filter in place.The inferior vena cava appears completely collapsed at this level and inferiorly suggesting chronic occlusion.There are multiple retroperitoneal venous collaterals with reconstitution of flow within the inferior vena cava just above the level of the filter.Around three years and two months later, computed tomography of abdomen without contrast was performed which revealed there was an inferior vena cava filter in low position at the level of l3-l4 on the right side.The tip was located about 5.6cm below the inflow over the renal veins.The tip was tilted anteriorly.The inferior vena cava below the level and of the inferior vena cava filter was collapsed or atretic.The anteroposterior diameter of the inferior vena cava was 2.7 centimeters proximally and 1.8 centimeters just above the inferior vena cava filter.The struts of the inferior vena cava filter extend into the left tissue adjacent to the atretic or collapsed inferior vena cava.There was no fluid collection in the pericaval space.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc), material deformation, filter tilt and occlusion of ivc.Additionally, it can be confirmed that the patient experienced pe 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.

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.At some time post filter deployment, it was alleged that the filter struts perforated.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: 12272825
• MDR Text Key: 264925887
• Report Number: 2020394-2021-80683
• 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: 08/04/2021

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: 07/08/2021
• Initial Date FDA Received: 08/04/2021
• 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: CLOPIDOGREL, RIVAROXABAN, LIPITOR, ASPIRIN; HYDROXYZINE HCL, COUMADIN; METOPROLOL TARTRATE, HYDROCODONE/ACETAMINOPHEN; ONDANSETRON AND AMITRIPTYLINE
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR
• Patient Weight: 80