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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F220A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Coagulation Disorder (1779); Pain (1994); Stenosis (2263); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 04/01/2021
Event Type  Injury  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported by the legal brief, a patient underwent placement of an optease vena cava filter. The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to stenosis and caval thrombosis. As a direct and proximate result of these malfunctions, the patient suffered life threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will suffer significant medical expenses, pain and suffering and other damages. Per the implant records the patient presented for spine decompression and fusion with a pulmonary embolus (pe) and a lower extremity deep vein thrombosis (dvt). The filter was indicated for the preoperative period. The bilateral groins were prepped and draped in the usual fashion. Using seldinger technique the right common femoral vein was catheterized with the inferior vena cava (ivc) filter introducer. An inferior cavagram was performed showing the location of the bilateral renal and iliac veins. The optease ivc filter was placed in the infrarenal position above the iliac bifurcation. A control inferior cavagram was performed showing successful positioning of the filter. The patient tolerated the procedure well. According to the information received in the patient profile form (ppf), the patient reports blood clots, clotting, occlusion of the ivc and stenosis, becoming aware of these events approximately five years and ten months after the filter implantation.
 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014 2802
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014 2802
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014-2802
7863138372
MDR Report Key12263538
MDR Text Key264710530
Report Number1016427-2021-05218
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2018
Device Model Number466F220A
Device Catalogue Number466F220A
Device Lot Number17199554
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 Received08/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2015
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: 08/02/2021 Patient Sequence Number: 1
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