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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number EC500F
Device Problems Migration or Expulsion of Device (1395); Extrusion (2934)
Patient Problems Atrial Fibrillation (1729); Perforation (2001)
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: the lot number has been provided and the lot device history records have been reviewed. The lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported for this lot number and issue to date. Medical records review: the patient presented for svc filter placement for prevention of pulmonary emboli with contraindication for anticoagulation status post pancreatic mass removal with bleeding complications and subsequent upper extremity dvt. The right internal jugular vein was accessed and venogram was obtained to assess the location and landmarks. The filter was then inserted and deployed at the proper location without any difficulty. Post-placement venogram was performed. No further information is noted regarding the patient¿s current status. Investigation summary: the device was not returned for evaluation. Images were not provided for review. Medical records were provided and reviewed. There was no specific deficiency alleged in the provided medical records. Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: warnings/potential complications: - movement, migration or tilt of the filter are known complications of vena cava filters. Migration of filters to the heart or lungs has been reported. There have also been reports of caudal migration of the filter. Migration may be caused by placement in ivcs with diameters exceeding the appropriate labeled dimensions specified in this ifu. Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens. - perforation or other acute or chronic damage of the ivc wall. Note: it is possible that complications such as those described in the "warnings", "precautions," or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted. 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 after being diagnosed with deep vein thrombosis/pulmonary embolism. At some time post filter deployment, the filter struts allegedly perforated into organs and the filter migrated to the right atrium; the device was successfully removed percutaneously. The patient allegedly experienced increased atrial fibrillation.

 
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Brand NameECLIPSE FILTER SYSTEM - FEMORAL
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 Key7138756
MDR Text Key95512369
Report Number2020394-2017-01787
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093659
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 12/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2015
Device Catalogue NumberEC500F
Device LOT NumberGFWI3166
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 Received11/28/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/05/2012
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: 12/21/2017 Patient Sequence Number: 1
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