MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

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 06/09/2016

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) 2011.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 (ivc) 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, recurrent dvt, 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) 2011.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 (ivc) 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

After further review of additional information received the following have been updated accordingly.The following additional information received per the patient profile from (ppf) indicates that the patient is suffering from anxiety.According to the medical records, the patient has a history of previous deep vein thrombosis dvt.The filter was implanted pre-operatively to hip surgery.The filter was deployed above the confluence of the iliac veins and the patient tolerated the procedure well.It was reported that a patient underwent placement of a trapease vena cava filter.The indication for the implant was pre-operative to hip surgery and a prior history of deep vein thrombosis (dvt).The device was implanted via the right common femoral vein without incident.The initial communication received indicated that 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 (ivc) 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.Information contained in the patient profile form indicates that no malfunction has occurred and that the device has been in place longer than ninety days and is too risky to be removed.The form also indicated that the patient is experiencing anxiety.There is currently no additional information available.The product was not returned for analysis.A review of the device history record (dhr) associated with lot 15285442 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.The trapease 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, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could be confirmed, nor is it possible to establish a relationship between the reported events and the device.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 6518205
• MDR Text Key: 73604151
• Report Number: 1016427-2017-00291
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• 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: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15285442
• 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
• Date Device Manufactured: 01/06/2011
• 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: 66 YR