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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466FXXXX
Device Problems Complete Blockage (1094); Difficult to Remove (1528)
Patient Problem Obstruction/Occlusion (2422)
Event Date 09/16/2019
Event Type  Injury  
Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter. The patient is reported to have had a history of blood clots. The indication for the filter placement was not reported. The filter was implanted via the right common femoral vein and placed in an infrarenal position. Approximately fourteen years after the filter implantation, the patient became aware that the filter had become occluded and was associated with blood clots, clotting and/or occlusion of the inferior vena cava (ivc). The patient also indicated that the filter was irretrievable; though attempts to retrieve it were not documented. The patient further reported having experienced anxiety associated with the filter. 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. The optease retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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. Stenosis, blood clots, clotting, embolism, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction. Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics. The anxiety experienced by the patient does not represent a device malfunction. Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry. Given the limited information available for review, there is nothing to suggest that a malfunction in 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 in 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 occlusion and device irretrievable with no documented attempts to remove the filter. Per the implant records, the patient was reported to have a clinical history of blood clots. The right groin was prepped and draped in the usual sterile fashion and the right common femoral vein was accessed using seldinger technique. An inferior vena cavogram was performed for measurement of the inferior vena cava (ivc) and sizing of the filter. The optease filter was then successfully deployed in the inferior vena cava just below the entrance of the renal veins. According to the information received in the patient profile form (ppf), the patient reports blood clots, clotting and occlusion of the ivc and further experienced anxiety related to the filter, becoming aware of these events approximately fourteen years after the filter implantation.

 
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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 ave
miami lakes FL 33014 2802
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014-2802
7863138372
MDR Report Key11046220
MDR Text Key222682349
Report Number1016427-2020-04639
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 OTHER
Reporter Occupation
Type of Report Initial
Report Date 12/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received12/03/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 12/21/2020 Patient Sequence Number: 1
Treatment
UNK WIRE, UNK GUIDEWIRE
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