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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 466F220B
Device Problems Fracture (1260); Migration (4003)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolus (1830); Occlusion (1984)
Event Date 06/25/2018
Event Type  Injury  
Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation. Please note that this is the initial report for this product. Additional information is pending and will be submitted within 30 days of receipt.

 
Event Description

As reported by the legal brief, the patient underwent placement of a optease vena cava filter. The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to fracture, embedment and occlusion. Information received per the medical records indicate that the patient has a history of deep vein thrombosis in left leg. The patient had a l5-s1 laminectomy approximately one month prior. The filter was deployed via the patient's right common femoral vein. In addition to the filter placement procedure, the patient also underwent left iliofemoral thrombectomy and angioplasty and stenting with two wallstents (14x90) for iliofemoral venous stenosis the same day. Information received per the patient profile form (ppf) states that the patient experienced filter fracture within the vena cava and the right ventricular wall, embedded, blood clots, clotting, and/or occlusion of the inferior vena cava (ivc). There was a removal attempt eight years and eight months after the index procedure and a second removal attempt eight years and ten months after the index procedure. Filter fragments remain within the patient's vena cava and right ventricular wall. The patient continues to experience worry, anxiety.

 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key10289013
MDR Text Key199703835
Report Number1016427-2020-04207
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466F220B
Device Catalogue Number466F220B
Device LOT NumberR0508396
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 Received07/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/30/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/17/2020 Patient Sequence Number: 1
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