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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SIMON NITINOL IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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BARD PERIPHERAL VASCULAR, INC. SIMON NITINOL IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Edema (1820); Pain (1994); Thrombosis (2100)
Event Date 08/21/2020
Event Type  Injury  
Event Description

Patient presented with back pain and bilateral lower extremity edema found to have acute on chronic occlusive ivc, bilateral iliac, and bilateral femoropopliteal dvt associated with an indwelling simon nitinol ivc filter placed 12 years prior for immobility during hospitalization. Patient underwent iliocaval reconstruction with exclusion of the ivc filter, stent placement in the ivc, right common iliac, external iliac, and common femoral veins, and left common and external iliac veins and extensive pharmacomechanical thrombectomy. Fda safety report id# (b)(4).

 
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Brand NameSIMON NITINOL IVC FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
MDR Report Key10493922
MDR Text Key205927347
Report NumberMW5096433
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/03/2020 Patient Sequence Number: 1
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