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 Coagulation Disorder (1779); Embolism (1829); Occlusion (1984); Thrombosis (2100)

Event Date 03/19/2014

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, blood clots, clotting and/or occlusion of the ivc, deep vein thrombosis (dvt), post-thrombotic syndrome and thrombosis/embolism.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 inferior vena cava (ivc) 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 procedural films available for review, it is not possible to clarify the location (proximal or distal) of the clots and thrombosis/embolism to the placement of the ivc filter.Blood clots and dvt¿s do not represent a device malfunction.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Deep vein thrombosis (dvt) occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Placement of a vena cava filter is not a cure for dvt/clots/thrombosis/embolism nor does it prevent the formation of them.Post thrombotic syndrome is a problem that can develop in nearly half of all patients who experience a dvt.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.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.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal team, the patient underwent placement of the trapease vena cava filter.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, dvt post-thrombotic syndrome and thrombosis/embolism.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 the trapease vena cava filter.The indication for the filter placement was not reported.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 inferior vena cava (ivc), deep vein thrombosis (dvt) post-thrombotic syndrome and thrombosis/embolism.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.According to the information received in the patient profile form, the patient became aware of the alleged failures thirteen years post implantation.The patient was admitted to the hospital for deep vein thrombosis.A computerized tomography scan at a later time also found thrombus within the filter.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 ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 procedural films available for review, it is not possible to confirm the presence of clots, thrombosis/embolism within the ivc or within the device.In addition, without these films, it is not possible to clarify the location (proximal or distal) of the clots and thrombosis/embolism in relation to the placement of the ivc filter.Blood clots and dvts do not represent a device malfunction.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called dvt.This occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Placement of a vena cava filter is not a cure for dvt/clots/thrombosis/embolism nor does it prevent the formation of them.Post thrombotic syndrome is a problem that can develop in nearly half of all patients who experience a dvt.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Given the limited information 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

According to the information received in the patient profile from (ppf), the patient became aware of the alleged failures thirteen years post implantation.The patient was admitted to the hospital for dvt.A ct scan at a later time found thrombus within the filter.Further examination reported postphlebitic syndrome.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 7698796
• MDR Text Key: 114327441
• Report Number: 1016427-2018-01662
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• 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
• Date Manufacturer Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1