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

Catalog Number 466P306X

Device Problems Occlusion Within Device (1423); Difficult to Remove (1528); Retraction Problem (1536); Appropriate Term/Code Not Available (3191)

Patient Problems Insufficiency, Valvular (1926); Occlusion (1984); Swelling (2091); Thrombosis (2100)

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including but not limited to, venous thrombosis in and above the inferior vena cava (ivc) filter, venous insufficiency, lower leg swelling, and failed removal attempt.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 thrombosis (blood clot) to the placement of the ivc filter.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency and lower leg swelling.There are possible patient and pharmacological factors that may have contributed to the reported event.Without procedural films for review, the reported filter retrieval difficulty could not be confirmed.However, the cordis trapease® permanent vena cava filter is designed as a permanent vena cava filter.Six straight struts that contain a proximal and distal hooks are designed for fixation of the trapease filter to the vessel wall.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The off label use of this filter likely contributed to the retrieval difficulty experienced by the customer.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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.

Event Description

As reported by the legal brief, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including but not limited to, venous thrombosis in and above the inferior vena cava (ivc) filter, venous insufficiency, lower leg swelling, and failed removal attempt.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

After further review of additional information received the following sections have been updated accordingly.The following additional information received per the medical records indicate that approximately on or about six months and twenty-seven days post implantation of the ivc filter, the patient underwent left common femoral vein angioplasty, percutaneous transluminal angioplasty and stenting of the left external iliac vein, left common iliac vein, right common iliac vein, and vena cava.Additionally, using ultrasound guidance, another non-cordis ivc filter was placed infrarenally after inferior cavagram was performed.Multiple attempts were used to extract the previously placed trapease filter with no success using multiple snares and wire technique.As a result, stenting over this filter was used to resolve the obstruction.One of the stents was placed from the right common iliac vein into the vena cava above the filter.When this stent was dilated, it was noted to crush the previously placed trapease filter.A completion venography was performed showing excellent patency of both the left and right iliac vein systems draining into the vena cava with brisk flow.According to the information received in the patient profile from (ppf), sometime post implantation of the ivc filter the patient reports to have ivc stenosis, occlusion of the ivc, blood clots, clotting, leg swelling, filter embedded in wall of the ivc, device unable to be retrieved, and suffer from severe fear, stress, anxiety, and loss of enjoyment of life.Approximately on or about six months and twenty-seven days post implantation of the ivc filter, an attempted but unsuccessful percutaneous removal procedure was performed.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

(b)(4).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, venous thrombosis in and above the inferior vena cava (ivc) filter, venous insufficiency, lower leg swelling, and failed removal attempt.According to the information received in the patient profile from (ppf), the patient reports to have ivc stenosis, occlusion of the ivc, blood clots, clotting, leg swelling, filter embedded in wall of the ivc, device unable to be retrieved, and suffer from severe fear, stress, anxiety, and loss of enjoyment of life.The patient¿s medical history and the indication for the device implant have not been provided.The medical records indicate that approximately six months and twenty-seven days post implantation of the ivc filter, the patient underwent left common femoral vein angioplasty, percutaneous transluminal angioplasty and stenting of the left external iliac vein, left common iliac vein, right common iliac vein, and vena cava.Additionally, using ultrasound guidance, another non-cordis ivc filter was placed infrarenally after inferior cavagram was performed.Multiple attempts were used to extract the previously placed trapease filter with no success using multiple snares and wire technique.As a result, stenting over this filter was used to resolve the obstruction.One of the stents was placed from the right common iliac vein into the vena cava above the filter.When this stent was dilated, it was noted to crush the previously placed trapease filter.A completion venography was performed showing excellent patency of both the left and right iliac vein systems draining into the vena cava with brisk flow.Approximately on or about six months and twenty-seven days post implantation of the ivc filter, an attempted but unsuccessful percutaneous removal procedure was performed.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 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.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in swelling of the affected extremity.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient, pharmacological factors and vessel characteristics may have contributed to these events.Without films of the index procedure or post implant imaging, the reported retrieval difficulty, could not be confirmed and could not be further clarified at this time.Anxiety does 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.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: 7347840
• MDR Text Key: 102711595
• Report Number: 1016427-2018-01256
• 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: 05/30/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/18/2018
• Supplement Dates Manufacturer Received: 04/19/2018; 05/24/2018
• Supplement Dates FDA Received: 05/17/2018; 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 37 YR