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 Pulmonary Embolism (1498); Coagulation Disorder (1779); Occlusion (1984); Pain (1994); Swelling (2091); Thrombosis (2100); Claudication (2550)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.Complaint conclusion: 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, acute embolism and ivc thrombosis requiring admission to the icu and a 25-day hospitalization (dates unknown), as well as thrombolytic therapy and swelling and pain in his lower extremities.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 patient¿s medical history includes chronic deep vein thrombosis (dvt)/embolism in lower extremities.The following additional information was received per the patient¿s implant records: the filter was implanted in the infrarenal inferior vena cava due to dvt and concern for cardiopulmonary compromise.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately three years and seven months post implantation.The patient reports experiencing blood clots, clotting, and/or occlusion of the ivc.The patient also reports suffering from anxiety.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.The anxiety experienced by the patient does not represent a device malfunction.Without procedural films available for review, it is not possible to clarify the location (proximal or distal) of the clots to the placement of the ivc filter.Blood clots and an ivc occlusion or embolism/thrombosis also do not represent a device malfunction.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency, possibly leading to lower extremity swelling and/or pain.Placement of a vena cava filter is not a cure for clots nor does it prevent the formation of a clot (thrombosis).Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics, as it is pointed out in the medical records provided that the patient¿s medical history includes chronic deep vein thrombosis (dvt)/embolism in lower extremities.Based on the 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 department, 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, acute embolism and ivc thrombosis requiring admission to the icu and a 25-day hospitalization (dates unknown), as well as thrombolytic therapy and swelling and pain in his lower extremities.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 patient¿s medical history includes chronic deep vein thrombosis (dvt)/embolism in lower extremities.The following additional information was received per the patient¿s implant records: the filter was implanted in the infrarenal inferior vena cava due to dvt and concern for cardiopulmonary compromise.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately three years and seven months post implantation.The patient reports experiencing blood clots, clotting, and/or occlusion of the ivc.The patient also reports suffering from anxiety.

• Brand Name: 466P306X
• 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 ; 7863138372
• MDR Report Key: 7661671
• MDR Text Key: 113155244
• Report Number: 1016427-2018-01616
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• 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: 06/07/2018
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 47 YR