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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN FILTER
Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Chest Pain (1776)
Event Date 08/01/2016
Event Type  Injury  
Manufacturer Narrative
A 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 two years and four months later, a unilateral leg venous ultrasound showed that there was no deep venous obstruction in the distal external iliac, common femoral, profunda femoral, femoral, popliteal or posterior tibial veins. After ten months, the patient presented with abdominal pain. On the same day, a right unilateral leg venous ultrasound showed that there was no deep venous obstruction in the distal external iliac, common femoral, profunda femoral, femoral, popliteal or posterior tibial veins. Also, an abdomen 1 view anteroposterior showed that an inferior vena cava filter was at the level of l2. After four weeks, the patient presented with right abdominal pain. On the next day, the patient presented with abdominal pain. On the same day, an abdomen series with upright posteroanterior chest showed that an inferior vena cava filter was present. After seven years and one month, an x-ray chest posteroanterior and lateral demonstrated that an inferior vena cava filter was seen. On the next day, a computed tomography angiography (cta) chest showed no evidence of acute pulmonary thromboembolic disease. An inferior vena cava filter was in place. After one year and nine months, the patient presented with chest pain and diagnosed with recurrent pulmonary embolism. After one week, a computed tomography angiography (cta) chest with intravenous contrast showed positive for the presence of small bilateral pulmonary emboli, especially in the upper and lower lobes. But the addendum of the report stated that upon further review, there was no definite evidence of acute pulmonary arterial thromboembolism identified. After five months, the patient presented with chest pain. On the same day, a computed tomography angiography (cta) chest with and without contrast showed no evidence of acute pulmonary embolism. There were 2 broken inferior vena cava filter struts in the right lower lobe. Additional broken strut of the inferior vena cava filter appeared to extend posteriorly in the retroperitoneum just beyond the apex of the filter. Also, an x-ray chest posteroanterior and lateral showed that the patient had inferior vena cava filter (probably bard type) with embolization of at least 3 broken struts with 2 of these were located in the right lower lung in the area of infiltrate and the third strut was located above and extended posterior to the inferior vena cava filter (uncertain exact anatomic location of this strut. The exact time course of the embolization of the struts was uncertain and whether or not the etiology of the infiltrate in the right lung base was from the struts was also uncertain). On the same day, a computed tomography (ct) abdomen and pelvis showed dislodged bard greenfield type inferior vena cava filter. There were 8 prongs seen attached to the apical portion of the filter. There was a ninth broken off prong seen lying posterior to the inferior vena cava near the apex of the filter. There was another broken off prong visualized in the right lower lobe of the lung posteromedially. Also, an x-ray chest anteroposterior demonstrated that there were 2 pieces of broken off prongs in the right lower lung, and the second of these prongs appeared to be in the right middle lobe. Therefore, the investigation is confirmed for the alleged filter limb detachment. However, the investigation is inconclusive for alleged perforation of the inferior vena cava. Additionally, it can be confirmed that the patient experienced pulmonary embolism post deployment. However, the relationship to the filter is unknown. 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.
 
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 and perforated. The device has not been removed and there were no reported attempts made to retrieve the filter. The two detached struts retained in right lower and/or middle lobe of lung and one strut near the apex of the filter. The patient experienced chest pain and was diagnosed with pulmonary embolism; however, the current status of the patient is unknown.
 
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Brand NameVENA CAVA FILTER
Type of DeviceVENA 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 Key11972467
MDR Text Key255597684
Report Number2020394-2021-80489
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 06/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN FILTER
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
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 Treatment Data
Date Received: 06/10/2021 Patient Sequence Number: 1
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