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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 Obstruction of Flow (2423); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001); Migration (4003)
Patient Problems Pulmonary Embolism (1498); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Event Date 03/22/2019
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: 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. After sometimes post deployment, the patient presented with right-sided abdominal pain, recurrent pulmonary embolism and diagnosed with status post inferior vena cava filter twice before. On the same day, a computed tomography (ct) abdomen and pelvis with intravenous contrast showed that an inferior vena cava filter was in place. After four years, the patient presented with lower back pain. On the same day, a computed tomography (ct) lumbar spine without intravenous contrast demonstrated that an inferior vena cava filter was noted in situ. After one year and nine months, a computed tomography (ct) chest without intravenous contrast showed that there were 2 filters within the inferior vena cava; 1 of which was infra renal and 1 of which was suprarenal and found within intrahepatic inferior vena cava. There was markedly dilated main pulmonary artery that measured 4. 7 cm in diameter versus 4. 3 cm on previous study, suggestive of pulmonary hypertension etiology of which could be chronic thromboembolic disease, given the extensive pulmonary embolism comparison or chronic pulmonary disease. After seven months, a computed tomography (ct) chest pulmonary embolism with intravenous contrast showed that there was no evidence of pulmonary embolism. Approximately, there was a 1. 5 cm long emboli at inferior vena cava filter leg in the right pulmonary artery. There was no evidence of associated thrombus. There was an additional filter leg in the anteromedial segment region. There was an embolized filter leg in the right ventricle with penetration into the inferior interventricular septum. There was additional filter leg that appeared to be in the pericardial space, that overlay the left ventricle. This was an unusual location, but might represent a previously perforated intracardiac fragment (partial perforation of other fragment). There were probably small filter leg fragments in the left lobe liver. Both suprarenal and infra renal inferior vena cava filters were noted. Therefore, the investigation is confirmed for the alleged filter limb detachment, filter occlusion and perforation of the inferior vena cava. However, the investigation is inconclusive for the alleged filter migration. 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 clogged, migrated,struts perforated and detached. The device has not been removed and there were no reported attempts made to retrieve the filter. It was further reported that the detached struts retained in right ventricle with penetration into septum and another leg in the pericardial space overlying the lateral left ventricle. Further more, filter fragments are in the left lobe liver and leg in the right pulmonary artery. The patient was diagnosed with pulmonary embolism post filter implant; 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 Key12187316
MDR Text Key262150678
Report Number2020394-2021-80575
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 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
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 Received06/22/2021
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: 07/19/2021 Patient Sequence Number: 1
Treatment
COUMADIN, UPTRAVI, SINGULAIR AND MACITENTAN; PREDNISONE, BACTRIM, DIOVAN AND CELLCEPT; SYNTHROID, LASIX, PRILOSEC AND TRACLEER
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