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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
Catalog Number 466F220A
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Stenosis (2263); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 02/04/2021
Event Type  Injury  
Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation. Please note that the exact event date is unknown and the event date is the complaint awareness date. 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 an 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 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 continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information received per the medical records indicate that the patient has a history of a fall with multiple lower left lower extremity fractures, multiple pelvic fractures and bilateral femoral vein deep venous thromboses. The filter was deployed via the patient's right femoral vein using the seldinger technique. There was adequate placement with no tilt. Placement was confirmed under fluoroscopy. The patient tolerated the procedure well. ¿ additional information received per the patient profile form (ppf) states that the patient experienced stenosis and caval thrombosis. The patient became aware of the reported events approximately twelve years and ten months after the index procedure. The patient also reported lightheadedness and that the filter is clogged which caused lack of blood flow, breathing difficulty and loss of stamina.

 
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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 Key12373690
MDR Text Key268441359
Report Number1016427-2021-05343
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 09/03/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number466F220A
Device LOT NumberR1207002
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 Received08/26/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/07/2007
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: 08/26/2021 Patient Sequence Number: 1
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