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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION UNKNOWN VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKFILTER
Device Problem Unintended Movement (3026)
Patient Problems Myocardial Infarction (1969); Perforation (2001); Perforation of Vessels (2135); Stenosis (2263)
Event Date 08/28/2020
Event Type  Injury  
Manufacturer Narrative

It was reported that a patient underwent placement of an unknown vena cava filter. The information provided indicated that the filter subsequently malfunctioned and caused stenosis, perforation and tilting. The indication for the filter placement and pertinent medical records have not been provided. There is currently no additional information available for review. The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed. An inferior vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated. The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart. Without procedural films for review, the reported events could not be confirmed or further clarified. Stenosis is an abnormal narrowing in a blood vessel and does not represent a device malfunction. Ivc filter tilt has been associated with practitioner technique and/or the anatomy of the vessel, specifically asymmetry and tortuosity. The ifu notes vessel damage such as intimal tears and perforation as a long-term and procedural complication related to ivc filters. Without post-placement imaging and the limited information provided, the report of organ perforation could not be confirmed or further clarified, nor a relationship between the device and the event be drawn. Given the limited information currently available for review, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken. Should additional information become available, the file will be updated accordingly.

 
Event Description

As reported by the legal brief, a patient underwent placement of an unspecified vena cava filter manufactured by cordis. The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to stenosis, perforation and tilting. As a direct and proximate result, 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.

 
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Brand NameUNKNOWN VENA CAVA 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 avenue
miami lakes FL 33014 2802
Manufacturer Contact
karla castro
14201 nw 60th avenue
miami lakes, FL 33014-2802
7863138372
MDR Report Key12169578
MDR Text Key261700153
Report Number9616099-2021-04710
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/14/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKFILTER
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 07/14/2021 Patient Sequence Number: 1
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