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

Catalog Number RF048F

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problems Chest Pain (1776); Foreign Body In Patient (2687)

Event Date 06/24/2010

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.Post deployment, a computed tomography angiography (cta) abdomen and pelvis with intravenous contrast showed that an inferior vena cava filter in infra renal position was identified.The struts of the vena cava filter extended beyond the inferior vena cava margins.The inferior vena cava was occluded at the level of the inferior vena cava filter.No intraluminal thrombus was noted.Approximately, two years of post-deployment, a computed tomography (ct) abdomen and pelvis with oral and intravenous contrast showed that there was an inferior vena cava filter.Around, one year five months later, a computed tomography (ct) chest with intravenous contrast showed no evidence of pulmonary embolism.Also, a ribs unilateral with posteroanterior chest left demonstrated that a bard inferior vena cava filter was noted in the abdomen with subsequent fracture.Three wire fragments, approximately 2.5 cm in length, in the left lung were probably from the inferior vena cava filter, embolized to the lungs.None were appreciated on the right side.After, two days, it was noted that several filter struts fractured and embolized into the lung.The filter was removed at first attempt with the bard system.Three fragments of the former filter were present in the left lung.With multiple catheters and wires, the physician was able to remove the 1 in the left lower lobe and the 1 in the post tear segment of the lingula but was not able to remove the last fragment.After, seven days, the patient presented with left lower chest pain and recently had 2 of 3 filter fragments removed.On the same day, a computed tomography (ct) pulmonary angiography with intravenous contrast showed negative for pulmonary embolism.Note was made of a thin linear inferior vena cava filter fragment within a small sub segmental pulmonary arterial branch of the lingula; this was chronic.No pericardial fluid or thickening was noted.After, four days, an attempt was made to remove the remaining fragment of the filter.A left pulmonary arteriogram demonstrated a single fragment of the former inferior vena cava filter was present in the left lung.Multiple attempts were made to select the pulmonary artery branch in the left lower lobe, that contained the fragment using multiple 5 french catheters and wires.At one point, the appropriate vessel was accessed, but attempts to gain purchase on the fragment using a snare were unsuccessful.The decision was made to discontinue the procedure since the fragment was small and extremely unlikely to be of harm.Hemostasis was accomplished by holding pressure.Around, two months and twenty-one days later, another attempt was made to remove the residual limb of embolized inferior vena cava filter within branch of the left pulmonary artery.By palpation, an 18-gauge needle was placed into the right common femoral vein.The wire and sheath were advanced into the right heart and subsequently into the pulmonary trunk and left main pulmonary artery, verified by fluoroscopy.Digital subtraction angiography showed that the linear metallic foreign body was identified in a lingular branch of the left pulmonary artery, probably the superior branch.The 12 french sheath was then exchanged for a bard di-rex multidirectional 8.5 french catheter and advanced to the origin of the lingular branch, that contained a foreign body.The wire was then exchanged for a 6 french amplatz gooseneck snare and the metallic foreign body was successfully snared and removed.Hemostasis was accomplished by holding pressure.Around, four months later, the patient presented with chronic left upper quadrant pain and left lower chest pain.On the same day, a computed tomography angiography (cta) chest showed that there was a new metallic foreign body in the right atrium.This foreign body was consistent with an inferior vena cava filter strut.After, two days, a transesophageal echocardiography demonstrated that the patient was found to have appeared with a fragment of known fractured inferior vena cava filter lodged within the tricuspid valve.It appeared that it was attached to the anterolateral leaflet of the tricuspid valve and lodged between it and the free wall of the right atrium.On some images, it appeared to be actually on the ventricular side.Some pieces have been taken out of the left pulmonary artery.The inferior vena cava filter was in malposition and multiple attempts at retrieval resulted in fragmentation.The patient had undergone multiple procedures over the last 6 months to retrieve the inferior vena cava filter fragments.On the next day, a computed tomography angiography (cta) scan demonstrated no evidence of pulmonary embolism, but with new pulmonary infarct.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc), filter limb detachment, malposition of the filter, retrieval difficulties, and occlusion of the inferior vena cava (ivc).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 detached.The device and the detached struts were removed percutaneously.It was further reported that the detached struts retained near the aorta.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: 12720962
• MDR Text Key: 279075575
• Report Number: 2020394-2021-80795
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• 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: 10/01/2021
• 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: ARIXTA
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 24 YR
• Patient Weight: 57