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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETREIVABLE VENA CAVA FILTER THROMBECTOMY SYSTEMS

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CORDIS CASHEL OPTEASE RETREIVABLE VENA CAVA FILTER THROMBECTOMY SYSTEMS Back to Search Results
Model Number 466FXXXX
Device Problems Filter (816); Occlusion Within Device (1423); Retraction Problem (1536)
Patient Problems Occlusion (1984); Thrombosis (2100)
Event Date 02/23/2017
Event Type  Injury  
Manufacturer Narrative

(b)(6). Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available. Patient demographics including medical history were not provided. If obtained, a follow up report will be submitted within 30 days upon receipt. As reported, the patient underwent placement of an optease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, inferior vena cava (ivc) thrombosis with thrombosis of the right common iliac vein and right external iliac vein, recurrent deep vein thrombosis (dvt) of lower extremity, and chronically occluded ivc filter, requiring angioplasty and stent placement, resulting in the filter being crushed/compressed. 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 and proximate result, the patient has suffered and will continue to suffer sig the product was not returned for analysis. Additionally, as the sterile lot number was not available, device history record review could not be performed. The inferior vena cava (ivc) 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. Thrombosis of the ivc, iliac veins, recurrent dvt¿s and occlusion of the ivc filter do not represent a device malfunction. Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency. Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics. Angioplasty and stenting of the ivc are treatments to maintain patency of the vena cava. Per the event described, these treatments were the cause of the filter being compressed/crushed. This was not a malfunction of the device. Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event. Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation 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, the patient underwent placement of an optease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, ivc thrombosis with thrombosis of the right common iliac vein and right external iliac vein, recurrent dvt of lower extremity, and chronically occluded ivc filter, requiring angioplasty and stent placement, resulting in the filter being crushed/compressed. 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 and proximate result, the patient, has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

 
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Brand NameOPTEASE RETREIVABLE VENA CAVA FILTER
Type of DeviceTHROMBECTOMY SYSTEMS
Manufacturer (Section D)
CORDIS CASHEL
cahir road
co. tipperary
cashel
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
co. tipperary
cashel
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7352490
MDR Text Key102867238
Report Number1016427-2018-01265
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466FXXXX
Device Catalogue Number466F220A
Device LOT NumberR1105425
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/23/2018
Event Location No Information
Date Manufacturer Received05/21/2018
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: 03/20/2018 Patient Sequence Number: 1
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