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

Model Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Occlusion (1984); Thrombosis (2100)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

As reported through the legal department via a legal brief, the plaintiff underwent placement of a trapease permanent inferior vena cava (ivc) filter.The filter subsequently malfunctioned, failed to perform as intended and caused injuries and damages to the plaintiff including, but not limited to, failing to prevent new pulmonary embolism.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, pain and suffering, and other damages.No additional information is available.  the product was not returned for inspection.Manufacturing records (dhr) could not be reviewed, as the product catalog and lot number are not available.  the cordis trapease® permanent vena cava filter is designed as a permanent vena cava filter.  six straight struts that contain a proximal and distal hooks are designed for fixation of the trapease filter to the vessel wall.  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.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 nor can a root cause be drawn; 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 a legal brief, the plaintiff underwent placement of a trapease permanent inferior vena cava (ivc) filter.The filter subsequently malfunctioned, failed to perform as intended and caused injuries and damages to the plaintiff including, but not limited to, failing to prevent new pulmonary embolism.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, pain and suffering, and other damages.No additional information is available.

Manufacturer Narrative

The following additional information received per the patient profile from (ppf) indicates that the patient had a blood clot in the right lung, clotting and occlusion of the ivc.The patient is currently on warfarin.According to the medical records, the patient¿s preoperative diagnosis were pelvic fracture, bilateral wrist and left shoulder fractures post a motorcycle accident, morbid obesity and was high risk for deep vein thrombosis (dvt).The filter was successfully deployed starting from the l2-l3 disk space parallel to the l3 vertebra without any reported complications.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported by the legal brief, the patient underwent placement of a trapease permanent inferior vena cava (ivc) filter.Per the medical records, the patient¿s preoperative diagnosis were pelvic fracture, bilateral wrist and left shoulder fractures post a motorcycle accident, morbid obesity and was high risk for deep vein thrombosis (dvt).The filter was successfully deployed starting from the l2-l3 disk space parallel to the l3 vertebra without any reported complications.The filter subsequently malfunctioned, failed to perform as intended and caused injuries and damages to the patient including, but not limited to, failing to prevent new pulmonary embolism (pe).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, pain and suffering, and other damages.The following additional information received per the patient profile from (ppf) indicates that the patient had a blood clot in the right lung, clotting and occlusion of the ivc.The patient is currently on warfarin.The product was not returned for analysis as it remains implanted.A review of the device history record (dhr) associated with lot r0607265 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.The trapease 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, pe and occlusive thrombosis within the filter do not represent a device malfunction.Clinical factors that may have influenced the event 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.

• 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: 6365179
• MDR Text Key: 68594919
• Report Number: 1016427-2017-00200
• 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,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0607265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/07/2017
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2007
• 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: 69 YR