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 Chest Pain (1776); Respiratory Distress (2045)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

As reported through the legal department via a legal brief, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, severe and constant chest pains and compromised respiratory system.As a direct and proximate result of these malfunctions, the plaintiff suffered serious injuries and damages and will require 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 trapease 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.As per the instructions for use (ifu), implantation of the trapease filter is contraindicated in patients with uncontrolled infectious disease.There are possible patient and pharmacological factors that may have contributed to the reported events of severe and constant chest pains and compromised respiratory system.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.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 a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, severe and constant chest pains and compromised respiratory system.As a direct and proximate result of these malfunctions, the plaintiff suffered serious injuries and damages and will require 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

After further review of additional information received the following sections have been updated accordingly.The following additional information received per the patient profile form (ppf) indicates the device was implanted due deep vein thrombosis (dvt) post injuries received from a motor vehicle accident.The patient is reported to experience back pain and continues to experience anxiety related to the device.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The following additional information received per the patient profile form (ppf) indicates the device was implanted due deep vein thrombosis (dvt) post injuries received from a motor vehicle accident.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, severe and constant chest pains and compromised respiratory system.As a direct and proximate result of these malfunctions, the patient suffered serious injuries and damages and will require 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 patient is reported to experience back pain and continues to experience anxiety related to the device.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.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 and thrombosis within the filter do not represent a device malfunction.Respiratory system disorders with symptoms of chest pain and shortness of breath do not represent a device malfunction and may be related to underlying patient comorbidities.Back pain does not represent a device malfunction and maybe related to underlying patient issues.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.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.Should additional information become available, the file will be updated accordingly.

• 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
• MDR Report Key: 6358223
• MDR Text Key: 68350817
• Report Number: 1016427-2017-00192
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: R0504224
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/31/2017
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: 12/07/2017; 02/16/2018
• Supplement Dates FDA Received: 01/05/2018; 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 31 YR