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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER VENA CAVA FILTER Back to Search Results
Catalog Number UNK ECLIPSE
Device Problem Obstruction of Flow (2423)
Patient Problems Edema (1820); Pain (1994); Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. Journal article citation: desai, k. R. , xiao, n. , karp, j. , salem, r. , rodriguez, h. , eskandari, m. , ¿ lewandowski, r. J. (2019). Single-session inferior vena cava filter removal, recanalization, and endovenous reconstruction for chronic iliocaval thrombosis. Journal of vascular surgery: venous and lymphatic disorders, 7(2), 176¿183. Doi: 10. 1016/j. Jvsv. 2018. 10. 014.

 
Event Description

It was reported in an article from the journal of vascular surgery titled " single-session inferior vena cava filter removal, recanalization, and endovenous reconstruction for chronic iliocaval thrombosis " that one patient presented with inferior vena cava filter (ivcf) related chronic iliocaval thrombosis resulting in severe venous stasis symptoms underwent single-session filter retrieval, followed by recanalization with stent placement and adjunctive iliofemoral thrombectomy as needed. Technical success was achieved after the procedure.

 
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Brand NameECLIPSE FILTER
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 Key9513330
MDR Text Key174564435
Report Number2020394-2019-05744
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 HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 12/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK ECLIPSE
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 Received11/25/2019
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: 12/23/2019 Patient Sequence Number: 1
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