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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466FXXXX
Device Problems Unintended Movement (3026); Migration (4003)
Patient Problems Perforation (2001); Stenosis (2263)
Event Date 07/14/2021
Event Type  Injury  
Manufacturer Narrative
Occupation: other, senior counsel, litigation. Please note that the exact event date is unknown and the event date is the complaint awareness date. 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, tilt, migration, stenosis and perforation of the filter. 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. The device was not returned for analysis. No lot number was provided therefore a product history record (phr) review could not be generated. The reported ¿filter-tilt, filter-migration, stenosis and perforation¿ could not be confirmed as the device was not returned for analysis. The exact cause of the reported events could not be conclusively determined. Procedural/handling factors, or vessel characteristics, although unknown, may have contributed to the reported event. According to the ifu, which is not intended as a mitigation of risk, ¿possible long-term complications associated with filter implantation include, but are not limited to, the following: filter obstruction, filter perforation of the vena cava wall, filter migration, filter fracture, recurrent pulmonary embolism. ¿ additionally, the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters. Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such. Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error. Physiologic causes of migration may result from temporary dysmorphism of the ivc including: bending, coughing or valsalva maneuvers resulting in dislodgment of the filter. Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters. Without images available for review the reported migration, tilt or perforation could not be confirmed or further clarified. The timing and mechanism of the tilt has not been reported at this time. It is unknown if the tilt contributed to the reported perforation. The reported stenosis does not represent a device malfunction. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. As no lot number or other product information was supplied a phr could not be completed. The limited information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time. Should additional information become available, the file will be updated accordingly. Please note that this is the initial report for this product.
 
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 tilt, migration, stenosis, and perforation of the filter. 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.
 
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Brand NameUNKNOWN OPTEASE VENA CAVA 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 Key12299066
MDR Text Key265775899
Report Number1016427-2021-05270
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/10/2021 Patient Sequence Number: 1
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