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

Catalog Number 466P306AU

Device Problem Occlusion Within Device (1423)

Patient Problems Embolus (1830); Occlusion (1984)

Event Date 05/31/2015

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to chronic occlusion of the filter itself.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, and pain and suffering, and other damages.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record 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.Occlusion of the ivc filter does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.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 placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to chronic occlusion of the filter itself.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, and pain and suffering, and other damages.

Manufacturer Narrative

The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the alleged events three years and seven months post implantation.The patient reports to have blood clots, clotting and occlusion of the inferior vena cava (ivc), stomach pain, and severe post-traumatic stress disorder (ptsd) and anxiety.The patient also notes to have undergone a clot busting procedure for the clogged filter and to have stage 3 kidney disease due to kidney trauma in the intensive care unit (icu).According to the information received in the medical records, the patient has history of recurrent lower extremity deep vein thrombosis (dvt) and pulmonary embolism (pe).During the filter placement procedure via the right internal jugular vein, the filter was deployed in the renal veins at the l3 level.The patient tolerated the procedure well.Additional information is pending and will be submitted within 30 days upon receipt.

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 injury and damages to the patient, including, but not limited to chronic occlusion of the filter itself.The patient became aware of the alleged events three years and seven months post implantation.The patient reports to have blood clots, clotting and occlusion of the inferior vena cava (ivc), stomach pain, and severe post-traumatic stress disorder (ptsd) and anxiety.The patient also notes to have undergone a clot busting procedure for the clogged filter and to have stage 3 kidney disease due to kidney trauma in the intensive care unit (icu).According to the information received in the medical records, the patient has history of recurrent lower extremity deep vein thrombosis (dvt) and pulmonary embolism (pe).During the filter placement procedure via the right internal jugular vein, the filter was deployed in the renal veins at the l3 level.The patient tolerated the procedure well.There is currently no additional information available for review.The product was not returned for analysis.A review of the device history record (dhr) associated with lot 15449277 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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.Without films of the index procedure or post implant imaging, the reported chronic occlusion of the filter could not be confirmed or further clarified at this time.Blood clots, clotting, 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 or a device malfunction could not be confirmed.Chronic kidney disease occurs when a disease or condition impairs kidney function, causing kidney.Prolonged obstruction of the urinary tract, from conditions such as enlarged prostate, kidney stones and some cancers can cause chronic kidney disease.With the limited information provided it is not possible to determine what may have contributed to the reported event, however, thromboembolism associated with a clot ¿busting¿ procedure may have been a contributing factor.Since the procedural notes, patient¿s medical history and procedural details have not been provided it is not possible to ascertain what may have caused the kidney disease.Anxiety, post-traumatic stress disorder 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.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.

• 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
• MDR Report Key: 7441072
• MDR Text Key: 105843759
• Report Number: 1016427-2018-01393
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15449277
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR