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

Catalog Number 466P306X

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

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Coagulation Disorder (1779); Embolus (1830); Respiratory Distress (2045); Thrombosis (2100)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.  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 patient, including, but not limited to, blood clots, recurrent deep vein thrombosis (dvts), and respiratory distress.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.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.The adverse events reported of blood clots, recurrent deep vein thrombosis (dvts), and respiratory distress do not represent a device malfunction.The instructions for use (ifu) lists possible procedure complications include, but are not limited to, the following: distal embolization, and thrombus formation.There are possible patient and pharmacological factors that may have contributed to the reported events of blood clots/clotting, recurrent deep vein thrombosis (dvts), and respiratory distress.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 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 patient, including, but not limited to, blood clots, recurrent deep vein thrombosis (dvts), and respiratory distress.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.No additional information is available.

Manufacturer Narrative

The following additional information received per the patient's medical records indicates the filter was implanted due to acute deep vein thrombosis in the left leg, pulmonary embolism and paranoid schizophrenia with medical non-compliance, causing a counterindication to anticoagulation.The patient was reported to have experienced pulmonary embolism after the filter was in place and required thrombolysis therapy.According to the patient profile form (ppf) the device is embedded and the patient continues to experience anxiety related to this device.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, recurrent deep vein thrombosis (dvts), and respiratory distress.The filter is also reported to be embedded and can¿t be retrieved.The patient¿s medical history is significant for paranoid schizophrenia and non-compliance with medication.The indication for the device implant was acute right leg deep vein thrombosis (dvt) and a contraindication to anticoagulation.The procedural implant records were not provided.Approximately three weeks post implant the patient presented with recurrent left leg swelling, tachycardia and risperdal overdose.In addition, the patient had shortness of breath and a documented pulmonary embolism on this admission.The medical records note that the patient had extensive iliofemoral and ivc and dvt up to the filter.The patient initially underwent placement of infusion catheters for an infusion of tissue plasminogen activator (tpa).The following day mechanical thrombolysis and thrombectomy was performed, but results were suboptimal.Infusion catheters were left in overnight with an infusion of (tpa).The patient was brought back the following day for venography and potential further intervention.The venogram revealed patient iliofemoral systems bilaterally with some residual thrombosis extending up into the ivc, but the filter appeared to be widely patent.Mechanical thrombectomy was then performed in the supra-renal vena cava and again, in addition to angioplasty of both iliac venous systems down to the femora heads.Completion venogram in the popliteal veins revealed wide patency of the superficial femoral vein up to the femoral and iliac veins.A flush catheter was then placed in the proximal most left common iliac vein and venogram including inferior vena cavogram obtained through this flushed catheter revealed wide patency of the ivc.These were felt to be acceptable results and the procedure was completed without complications.There is currently no additional information available.There is currently no additional information available.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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.The reported ¿filter embedded in wall of the ivc¿ and retrieval difficulty, could not be confirmed and could not be further clarified at this time.The reported event notes implantation of the filter on or about december 2006; however, the attempted retrieval date or an actual attempt at retrieval, is unknown at this time.Blood clots, clotting, device occlusion related to clotting and post procedural pulmonary embolism do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.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.Respiratory distress does 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.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.Should additional information become available, the file will be updated accordingly.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days of receipt.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• 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: 6686240
• MDR Text Key: 79060153
• Report Number: 1016427-2017-00442
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2018

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 Catalogue Number: 466P306X
• Device Lot Number: R0706523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/09/2017
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 01/22/2018; 02/20/2018
• Supplement Dates FDA Received: 02/21/2018; 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2006
• 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: 34 YR