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

Model Number 466P306AU

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

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Swelling (2091); Thrombosis (2100)

Event Date 02/23/2010

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

According to the information received in the patient profile from (ppf), , the patient underwent placement of the trapease vena cava filter due to progressive deep venous thrombosis of the left lower extremity.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting, and/or occlusion of the ivc, ivc stenosis, leg swelling, impaired venous return, impaired cardiac functional reserve due to ivc syndrome.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

As reported, the patient underwent placement of a trapease filter.According to the information received in the patient profile from (ppf), the patient underwent placement of the trapease vena cava filter due to progressive deep venous thrombosis of the left lower extremity.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting, and/or occlusion of the ivc, ivc stenosis, leg swelling, impaired venous return, impaired cardiac functional reserve due to ivc syndrome.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.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 inferior 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 possibly leading to swelling of the lower extremities.These reported events do not represent a device malfunction.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).Without images or procedural films for review, the reported vena cava stenosis and ivc syndrome could not be confirmed and the exact cause could not be determined.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.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, tipperary 0000 ; EI 0000
• MDR Report Key: 7536782
• MDR Text Key: 109003770
• Report Number: 9616099-2018-02147
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

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 Expiration Date: 11/30/2012
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15075387
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/01/2018
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE WIREUNKNOWN SHEATH UNKNOWN CATHE; UNKNOWN GUIDE WIREUNKNOWN SHEATH UNKNOWN CATHE
• Patient Outcome(s): Other
• Patient Age: 59 YR