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

Model Number 466P306X

Device Problem Failure to Align (2522)

Patient Problems Embolus (1830); Pain (1994); Perforation of Vessels (2135); Distress (2329); Injury (2348)

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

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 tilting of the filter and the resultant symptoms.The indication for the filter implant has not been provided and there is currently no additional information available for review.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.Without images or procedural films for review, the reported filter tilt could not be confirmed, and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.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.

Event Description

As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, physical and emotional damages from tilting of the filter and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, distress and other damages.

Manufacturer Narrative

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

Event Description

Additional information received per the medical records indicate that the patient has a history of pulmonary embolism (pe), bilateral possible, pulmonary infarct, hypoxemia, acute kidney injury, complains of cough with yellowish sputum and shortness of breath for one week prior to implant.Immediately prior to the index procedure the patient was admitted to the hospital for bilateral pulmonary embolus, infiltrate consistent with infarction, hypoxemia and bilateral lower extremity deep vein thrombosis.  additional information received per the patient profile form (ppf) states that the patient experienced filter perforation/abutting the wall of the inferior vena cava and tilting of the filter.The patient became aware of the reported events approximately eight years after the index procedure.The patient has also suffered psychologically and experienced breathing problems and swollen legs.The results of computed tomography (ct) scans done approximately eight years after the index procedure indicate that the filter was tilted, angled towards/abutting the anterior wall of the inferior vena cava (ivc).None of the ivc filter struts were definitively extending outside of the lumen.The scan also revealed a ventral hernia which contains a portion of small bowel as well as a few blood vessels and several collateral blood vessels are seen within the anterior and lateral abdominal subcutaneous soft tissues bilaterally.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, g4, g7, h1 and h2.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 tilt of the inferior vena cava (ivc) filter.The patient reported becoming aware of filter perforation/abutting the wall of the inferior vena cava and tilting of the filter, approximately eight years after the index procedure.The patient also reports experiencing anxiety, breathing problems and swollen legs.According to the medical records, the patient had a history of bilateral pulmonary embolism (pe) with pulmonary infarct, hypoxemia, acute kidney injury, and bilateral lower extremity deep vein thrombosis.The procedural details were not provided.Approximately eight years post implant the patient underwent a computed tomography (ct) scan to evaluate the filter.Results of the scan noted that the filter was tilted, angled towards/abutting the anterior wall of the inferior vena cava (ivc), none of the filter struts were definitively extending outside of the lumen and several collateral blood vessels are seen within the anterior and lateral abdominal subcutaneous soft tissues bilaterally.The scan also revealed a ventral hernia which contains a portion of small bowel as well as a few blood vessels.There is currently no additional information available for review.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 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.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu), noting vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.It is unknown if the tilt contributed to the perforation.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency, resulting in swelling and discoloration of the affected extremity.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds and result in edema of the extremity.Collateral circulation develops as a result of inherent circulation patterns being impeded.Shortness of breath and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided a clinical conclusion as to the cause of the events could not be determined.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: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9535273
• MDR Text Key: 173972571
• Report Number: 1016427-2019-03712
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15443375
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 02/14/2020; 03/14/2020
• Supplement Dates FDA Received: 03/10/2020; 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR