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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL 466F220A FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL 466F220A FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F220A
Device Problems Occlusion Within Device (1423); Failure to Align (2522)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Occlusion (1984); Perforation (2001); Swelling (2091); No Code Available (3191)
Event Date 07/28/2016
Event Type  Injury  
Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date. As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter. The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: filter tilted, became embedded, occluded and is perforating the vena cava wall. 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, and pain and suffering, and other damages. No additional information is available. 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 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. Blood clots within the device or occlusion of the device does not represent a device malfunction. Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation of the filter. Without procedural films for review, the filter tilt reported could not be confirmed. Additionally, the timing and mechanism of the filter tilt is unknown. The legal briefing mentioned a perforation. Without procedural films available for review, the reported perforation could not be confirmed. With the information available it is not possible to draw a clinical conclusion to the reported event, and the exact cause could not be determined. It is unknown if the tilt contributed to the reported perforation. The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters. Endothelialization, remodeling/restructuring of the internal lumen of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days. Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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. Please note that this is the initial/final report for this product.

 
Event Description

As reported through the legal department via legal brief, the patient underwent placement of an optease inferior vena cava (ivc) filter. The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: filter tilted, became embedded and occluded, and is perforating the vena cava wall. 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, and pain and suffering, and other damages. No additional information is available.

 
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Brand Name466F220A
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel co., tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel co., tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7626943
MDR Text Key111979854
Report Number1016427-2018-01565
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberUNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 10/12/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2016
Device MODEL Number466F220A
Device Catalogue Number466F220A
Device LOT Number15999199
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/25/2018
Event Location No Information
Date Manufacturer Received10/04/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/06/2013
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: 06/21/2018 Patient Sequence Number: 1
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