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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); Device Operates Differently Than Expected (2913); Extrusion (2934); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Perforation (2001)
Event Date 03/29/2010
Event Type  Injury  
Manufacturer Narrative

No device or medical images have been made available to the manufacturer. As the lot number for the device was not provided, a review of the device history records could not be performed. The investigation of the reported event is currently underway. Medical records were received and reviewed. Patient had a vena cava filter deployed successfully for protection of dvt and pe. A ct scan performed five years post vena cava filter deployment demonstrated four filter limbs perforated the ivc wall. Based on medical records received, no attempts were made to retrieve the vena cava filter. 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 that approximately five years post vena cava filter deployment for protection of dvt and pe for a surgical procedure; a ct scan demonstrated four filter limbs perforating the ivc wall. Based on the medical records provided, no attempt was made to retrieve the vena cava filter. Patient was reported to be asymptomatic.

 
Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Image/photo review:no medical images have been made available to the manufacturer. Conclusion: the device was not returned. Medical records were provided. The medical records allege a ct scan demonstrated four filter limbs perforating the ivc wall. The patient was reportedly asymptomatic. Based on the medical records, the investigation is confirmed for perforation of the ivc. Based upon the available information, the definitive root cause for filter perforation is unknown. It is unknown if patient or procedural factors contributed to the reported event. Labeling review: the current ifu (instructions for use) states: - potential complications: perforation or other acute or chronic damage of the ivc. 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.

 
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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 Key5198242
MDR Text Key30514149
Report Number2020394-2015-01793
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,Followup,Followup
Report Date 06/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2015
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 Received06/02/2020
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: 11/03/2015 Patient Sequence Number: 1
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