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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - JUGULAR VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - JUGULAR VENA CAVA FILTER Back to Search Results
Catalog Number MD800J
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Extrusion (2934)
Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Chest Pain (1776)
Event Date 06/25/2013
Event Type  Injury  
Manufacturer Narrative

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. This is the only event reported to date for this lot number and failure mode. Medical records review: this patient with deep vein thrombosis (dvt) and pulmonary embolism (pe) had a vena cava filter deployed in the suprarenal inferior vena cava (ivc) due to a mega cava. Post deployment cavogram demonstrated adequate alignment of the filter with the caval lumen and some extra distribution of the filter legs. Approximately one year and four months post filter deployment, the patient had stopped anticoagulation, was admitted to the hospital for chest pain and found to have evidence of pe along with dvt. The patient was started on anticoagulation and discharged four days later. Approximately five years and six months post filter deployment, an ultrasound of the abdomen demonstrated retroperitoneal varices. Approximately one month later, the patient was evaluated for filter removal for abdominal pain. The physician reviewed a computed tomography scan of the abdomen and indicated that the filter appeared to have a strut exiting the ivc at the level of the liver. The patient was scheduled for retrieval of the filter and the filter was retrieved with difficulty using a snare sheath combination. The filter was inspected and all the struts appeared to be present without any breakage. The post-removal venogram showed no extravasation of contrast. The patient tolerated the procedure well. There were no complications. Investigation summary: the device was not returned for evaluation and images were not provided for review. However, medical records were provided and reviewed. Based on the medical records, it can be confirmed the patient experienced pe after filter implantation; however, the origin and relationship to the filter has not been established in the provided medical records. Additionally, the investigation can be confirmed for perforation of the ivc wall and difficulties removing the filter. The investigation is inconclusive for a tilted filter. 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. Expiry date: 12/2012; 12/2011. - the information provided by bard 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 bard.

 
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 and due to right heart strain. At some time post filter deployment, it was alleged that the filter perforated organs, tilted and embedded. The device was removed percutaneously. Reportedly, the patient experienced pulmonary embolism and deep vein thrombosis post filter implant; however, the status of the patient is unknown.

 
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Brand NameMERIDIAN FILTER SYSTEM - JUGULAR
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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7546660
MDR Text Key109361333
Report Number2020394-2018-00740
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK102511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 05/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberMD800J
Device LOT NumberGFVL0145
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2018
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: 05/25/2018 Patient Sequence Number: 1
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