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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - JUGULAR VENA CAVA DEVICE Back to Search Results
Catalog Number EC500J
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528)
Patient Problem Death (1802)
Event Date 05/24/2012
Event Type  Death  
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 one year and three months post filter deployment, an attempt was made to retrieve the filter. Through the right internal jugular vein access, bard retrieval system was placed into the inferior vena cava. Subsequently an inferior vena cavagram demonstrated that the filter appeared to be central. The hook appeared to be free in 2 views centrally. However, despite using the retrieval device, a 22 mm snare, a 7 mm snare, jr-4 multipurpose a2 catheter and modified right amplatz catheter, filter was not able to capture and remove it. Eventually five days later, second attempt was made to retrieve the moved filter, which occurred during previous filter retrieval procedure. Through the right internal jugular vein access, using the sheath of the bard cone retrieval device and captured the filter, but could not capture the head of it. An n-snare was used to grab the filter by using the bard cone device to centralize the filter. The end snare grabbed the filter, folded and came out of the 8-french sheath. Subsequently few days later, the patient was expired. Therefore, the investigation is confirmed for retrieval difficulties. However, the investigation is confirmed for filter migration. 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.

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with bilateral pulmonary emboli and congestive heart failure. Approximately one year and three months post filter deployment, it was alleged that the filter moved and difficult to remove. The device was removed percutaneously. The patient reportedly expired; however, the current status of the patient is unknown.

 
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Brand NameECLIPSE FILTER SYSTEM - JUGULAR
Type of DeviceVENA CAVA DEVICE
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 Key11331706
MDR Text Key231952858
Report Number2020394-2021-80162
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
Type of Report Initial
Report Date 02/16/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/16/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberEC500J
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 Received01/20/2021
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: 02/16/2021 Patient Sequence Number: 1
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