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 Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombosis (2100)

Event Date 12/28/2018

Event Type  Injury  

Manufacturer Narrative

The exact catalog and lot number are not known.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by 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: blood clotting, occlusion of the ivc, and filter embedded in the wall of the ivc and cannot be retrieved.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, patient has suffered and will continue to suffer significant medical expense, and pain and suffering, and other damages.

Manufacturer Narrative

As reported, the patient underwent placement of 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: blood clotting, occlusion of the ivc, and filter embedded in the wall of the ivc and cannot be retrieved.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Blood clots 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

After further review of additional information received the following sections b4, g4, g7, h2, and h6 have been updated accordingly.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 blood clotting, occlusion of the inferior vena cava (ivc), and filter embedded in the wall of the ivc and cannot be retrieved.The patient reports leg swelling, clotting and thrombosis.Approximately eight years and two months post implant the patient presented to the hospital for leg swelling.A computed tomography scan revealed extensive thrombosis of the distal ivc without contrast.A follow up ct with contrast showed thrombosis of the ivc below the level of the filter and iliac veins bilaterally.The patient underwent mechanical thrombectomy and balloon angioplasty of the ivc, left common iliac vein, common femoral vein, and left femoral vein.This was followed by another mechanical thrombectomy with balloon angioplasty 2 days later.The patient was told that the filter is embedded and can no longer be removed.The patient continues to have pain and clotting in the legs and lives with anxiety and worry because of the condition of the filter.The indication for the filter placement and the patient¿s medical history have not been provided.The filter was placed via the right femoral vein and deployed in the infrarenal ivc.The patient tolerated the procedure with no apparent injury.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 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 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.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 device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Anxiety, pain and leg swelling do 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.

Event Description

The following additional information was received per the patient¿s implant records: antegrade percutaneous access was performed through the right femoral vein.A 6f sheath was inserted.Filter was prepped and advanced over the wire.Catheter inserted via guidewire.Filter was inserted and deployed.Hemostasis was achieved by manual pressure.The patient tolerated the procedure with no apparent injury.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 8 years and 2 months post implantation.The patient reports leg swelling, clotting and thrombosis.A ct revealed extensive thrombosis of the distal ivc and of the ivc below the level of the filter and iliac veins bilaterally.The filter is embedded and can no longer be removed.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
• MDR Report Key: 8287488
• MDR Text Key: 134604785
• Report Number: 1016427-2019-02458
• 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: 08/21/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• 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: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening