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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 Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Unintended Movement (3026)
Patient Problems Coagulation Disorder (1779); Emotional Changes (1831); Pain (1994); Perforation (2001); Perforation of Vessels (2135); Stenosis (2263); Thrombosis/Thrombus (4440)
Event Date 02/15/2021
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 perforation, tilting, clot in the filter, 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 was reported to have a preoperative diagnosis of severe obesity. The right groin was prepped and draped into a sterile field. The right common femoral artery and the vein medical to this, was identified using doppler and the vein was cannulated using seldinger technique. A guidewire, dilator and introducer were sequentially advanced over the guidewire to the proximal right common iliac vein. A venogram was performed followed by an inferior vena cavagram and the diameter of the inferior vena cava at the point of deployment of the filter was measured. The filter was deployed in the distal inferior vena cava. The patient tolerated the procedure well.
 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
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 Key12238782
MDR Text Key264037956
Report Number1016427-2021-05146
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466F220A
Device Catalogue Number466F220A
Device Lot NumberR1107244
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 Received07/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2007
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: 07/28/2021 Patient Sequence Number: 1
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