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

Model Number 466FXXXX

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the plaintiff is a citizen and resident of (b)(6).The plaintiff underwent placement of defendants' optease vena cava filter on or about (b)(6) 2010.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (lvc) filter, and recurrent deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) review could not be performed.The optease 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.Neither blood clots, clotting, nor thrombus within the vessel (or in the filter) represent a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.The product¿s instructions for use (ifu) indicate that filter obstruction, blood clots and thrombus formation are potential complications of filter implantation.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.

Event Description

As reported by the legal brief, the plaintiff is a citizen and resident of (b)(6).The plaintiff underwent placement of defendants' optease vena cava filter on or about (b)(6) 2010.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (lvc) filter, and recurrent deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

The following additional information received per the patient profile from (ppf) indicates that six years and a month post implantation the ivc was occluded.The patient also reports to be suffering from chest pain.According to the medical records, the patient had a history of pulmonary embolism (pe) with acute dvt.The filter was successfully deployed below the renal veins during the index procedure and the patient tolerated the index procedure well.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the medical records, the patient had a history of pulmonary embolism (pe) with acute dvt.The filter was successfully deployed below the renal veins during the index procedure and the patient tolerated the index procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (lvc) filter, and recurrent deep vein thrombosis (dvt).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.The following additional information received per the patient profile from (ppf) indicates that six years and a month post implantation the ivc was occluded.The patient also reports to be suffering from chest pain.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) review could be performed.The optease 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 and occlusive thrombosis within the filter and ivc do not represent a device malfunction.Chest pain does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, 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.Corrected data: manufacturer name, city and state.Mdr reporting contact name and address.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6515732
• MDR Text Key: 73493718
• Report Number: 1016427-2017-00287
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/30/2017
• Date Manufacturer Received: 12/05/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 54 YR