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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Event Date 05/08/2010
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. Approximately five years and four months later, the patient came to the hospital with severe chest pain and had syncope. Cardiac catheterization, which showed evidence of double vessel coronary artery disease. The patient had an echocardiogram done emergently on the table which showed evidence of cardiac tamponade. After the next day, a computed tomography angio (cta) aorta with and without contrast was performed and it revealed a 2 cm linear metallic structure in the region of the myocardial septal wall which may be the etiology for the pericardial effusion. This structure probably represents one of the outer prongs of the inferior vena cava filter. After the next day, a chest single view was performed, and compared to the prior study shows new linear radiopaque opacities projecting over the right side of the heart. After the next day, the patient scheduled for the filter strut removal. A median sternotomy was carried out following which pericardium was opened. Following this, the right ventricle was mobilized upwards and there was evidence of foreign body perforating through the diaphragmatic surface of the right ventricle and this was extracted from the right ventricle. This was extracted for an inferior vena cava filter which was taken out and sent for pathological analysis. Following this, cross-clamp was placed and antegrade and retrograde cardioplegia was given. After the electromechanical arrest of the heart, a bypass was done to the posterior descending artery as well as to the obtuse marginal branch of the circumflex coronary artery. Therefore, the investigation is confirmed for alleged filter limb detachment. However, the investigation is inconclusive for the perforation of the inferior vena cava (ivc). 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 in conjunction with trauma situation/motor vehicle accident. At some time post filter deployment, it was alleged that the filter struts detached and perforated into the organs. The device has not been removed and there were no reported attempts made to retrieve the filter. The detached struts was removed via open chest procedure; however, the current status of the patient is unknown.

 
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Brand NameRECOVERY FILTER SYSTEM
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 Key10198919
MDR Text Key196584567
Report Number2020394-2020-04073
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031328
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 06/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF048F
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 Received06/05/2020
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: 06/26/2020 Patient Sequence Number: 1
Treatment
AMLODIPINE, ASPIRIN, ATORVASTATIN, DIVALPROEX; DOCUSATE SODIUM, HEPARIN SODIUM, INSULIN; LACOSAMIDE, METFORMIN; PANTOPRAZOLE AND SITAGLIPTIN
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