MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

Device Problem Complete Blockage (1094)

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

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.(b)(4).

Event Description

As reported by the legal brief, 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, occlusion of the ivc filter, thrombosis, filter cannot be retrieved, and post-thrombotic syndrome due to the filter failing.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical are and treatment.As a further and proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other malfunctions.

Manufacturer Narrative

As reported, patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, occlusion of the ivc filter, thrombosis, filter cannot be retrieved, and post-thrombotic syndrome due to the filter failing.The filter remains implanted; thus, unavailable for analysis.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.Blood clots, post thrombotic syndrome and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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.

Manufacturer Narrative

According to the information received in the patient profile from (ppf), the patient became aware of the events ten years post implantation.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.A ct scan of the patient performed approximately ten years post implantation noted an acute thrombus in the right lower extremity of the common femoral, profunda, superficial femoral, popliteal posterior tibial and peroneal veins; along with an acute thrombus in the left lower extremity of the external iliac, common femoral, profunda, superficial femoral, popliteal, posterior tibial and peroneal veins.The ct scan report noted a chronic narrowing and occlusion of the ivc and iliac veins below the filter.There is also retroperiotoneal and inferior epigastric venous collaterals secondary to this chronic obstruction.The patient further states he suffers from lack of blood flow to the liver causing cirrhosis of the liver, ulcers in the legs due to lack of blood flow, pain in the abdomen area and lower back, pain in the chest area, and swelling of the legs due to these complications.These injuries have caused emotional distress, mental anguish, anxiety and stress.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently became occluded had thrombus, could not be retrieved and the patient experienced post-thrombotic syndrome as a result.A computed tomography (ct) scan performed approximately ten years post implant noted an acute thrombus in the right lower extremity of the common femoral, profunda, superficial femoral, popliteal posterior tibial and peroneal veins; along with an acute thrombus in the left lower extremity of the external iliac, common femoral, profunda, superficial femoral, popliteal, posterior tibial and peroneal veins.The ct scan report noted a chronic narrowing and occlusion of the ivc and iliac veins below the filter.There are also retroperitoneal and inferior epigastric venous collaterals secondary to this chronic obstruction.The patient further states a lack of blood flow to the liver causing cirrhosis of the liver, ulcers in the legs due to lack of blood flow, pain in the abdomen area and lower back, pain in the chest area, and swelling of the legs due to these complications, resulting in stress and anxiety.The patient¿s medical history and procedural details of the implant have not been provided.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 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.Following implant, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts, making retrieval difficult.Blood clots, clotting and/or occlusion of the inferior vena cava or the filter does not represent a device malfunction.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Post-thrombotic syndrome (pts) is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis (blood clot) in the leg.Pts symptoms include chronic leg pain, swelling, redness, and ulcers (sores).There are a wide range of disease that can cause cirrhosis of the liver, primarily alcoholism and hepatitis.It is unlikely that occlusion of the ivc contributed to the reported event, particularly with the formation of collateral circulation.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.With the very limited information provide it is not possible to make a determination as to what may have contributed to the reported events.There is nothing in the limited information available for review 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: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8289038
• MDR Text Key: 134493834
• Report Number: 1016427-2019-02465
• 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,Followup
• Report Date: 04/05/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• 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: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1