MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

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

Patient Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Thrombosis (2100)

Event Date 06/03/2008

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment of deep vein thrombosis (dvt) and pulmonary embolism.The device was implanted into the patient's renal veins.The device in the patient was positively identified by medical records.On or about 9 days after the procedure, the patient received an exam on the chest which showed that the patient suffered from multiple bilateral pulmonary embolism and deep venous thrombosis status post inferior vena cava (ivc) filter placement.As a result of the malfunction of the trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care and treatment.Plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.The product was not returned for analysis.Additionally, as the sterile lot number was not available, the device history record (dhr) review could not 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 that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation of the device; therefore no corrective action will be taken.

Event Description

As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment of deep vein thrombosis (dvt) and pulmonary embolism.The device was implanted into the patient's renal veins.The device in the patient was positively identified by medical records.On or about 9 days after the procedure, the patient received an exam on the chest which showed that the patient suffered from multiple bilateral pulmonary embolism and deep venous thrombosis status post inferior vena cava (ivc) filter placement.As a result of the malfunction of the trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care and treatment.Plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.

Manufacturer Narrative

According to the patient profile form (ppf), the filter was implanted via the right common femoral vein and deployed in the infrarenal area without difficulty and there were no immediate complications.The patient is experiencing blood clots, clotting and/or occlusion of the ivc, leg and back pain and is suffering from mental anguish related to the device.The product remains implanted and is thus not available for analysis.A review of the manufacturing records could not be conducted without a lot number.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

It was reported that a patient underwent a procedure to implant a trapease permanent vena cava filter.The information provided indicated that on or about nine days after the procedure, the patient received an exam of the chest which showed that the patient suffered from multiple bilateral pulmonary embolism and deep venous thrombosis status post inferior vena cava (ivc) filter placement.Pre-implant records and/or imaging of the chest have not been provided.The information also indicated that the patient is experiencing blood clots, clotting and/or occlusion of the ivc, leg and back pain and is suffering from mental anguish related to the device.The indication for the device implant was deep vein thrombosis (dvt) and pulmonary embolism.The filter was implanted via the right common femoral vein and deployed in the infrarenal area without difficulty and there were no immediate complications.There is currently no additional information available.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 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.Pulmonary embolism and filter occlusion are known long term complications associated with filter implant and are listed as such in the instructions for use (ifu).Clotting, pulmonary emboli 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 a device malfunction could not be confirmed.Anxiety and pain do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported events and the device.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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 Key: 6898253
• MDR Text Key: 87617607
• Report Number: 1016427-2017-00622
• 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: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• 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: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• 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: 45 YR