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); Calcium Deposits/Calcification (1758); Embolus (1830); Occlusion (1984); No Code Available (3191)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment of deep vein thrombosis (dvt).The device was implanted into the patient¿s right internal jugular vein.The device was positively identified by the patient¿s medical records.On or about eight years and eight months after the procedure, the patient received a scan on the abdomen and pelvis.The scan showed that the patient has extensive calcification that was seen within the inferior vena cava (ivc) filter.The venous flow of the patient¿s lower leg were being drained through collaterals in the subcutaneous tissues of the trunk.As a result of the malfunction of the trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.The product was not returned for analysis.Additionally, as the sterile lot number was not available, the device history record review could not be performed.The trapease inferior 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.Calcification is the accumulation of calcium salts in a body tissue.It is transported through the blood stream.Calcification normally occurs in the formation of bone, but calcium can be deposited abnormally in any part of the body, causing it to harden.Calcification within a patient does not represent a device malfunction.The brief also mentioned collateral circulation.Collateral circulation is the circulation of blood established through enlargement of minor vessels and anastomosis of vessels with those adjacent parts when a major vein or artery is functionally impaired.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or malfunction of the filter.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.(b)(4).

Event Description

As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment of deep vein thrombosis (dvt).The device was implanted into the patient¿s right internal jugular vein.The device was positively identified by the patient¿s medical records.On or about eight years and eight months after the procedure, the patient received a scan on the abdomen and pelvis.The scan showed that the patient has extensive calcification that was seen within the inferior vena cava (ivc) filter.The venous flow of the patient¿s lower leg were being drained through collaterals in the subcutaneous tissues of the trunk.As a result of the malfunction of the trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care and treatment.Plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.

Manufacturer Narrative

According to the procedural note the filter was implanted via the right internal jugular vein, with successful deployment in the infra-renal location.A central venous catheter was placed immediately following the ivc filter implant.The indication for the filter implant was bleeding, a history of dvt and abdominal pain.The results of a computerized tomography (ct) scan of the abdomen and pelvis performed approximately eight years and eight months after the filter implant showed extensive calcifications shown within the filter.The patient appears to be draining the venous flow the lower legs through collaterals in the subcutaneous tissues of the trunk.According to the patient profile form (ppf), the patient became aware approximately eight years and eight months after the implant that the filter was embedded in the wall of the inferior vena cava (ivc), embedded other then in the wall of the ivc, that there were blood clots, clotting and/or occlusion of the ivc, the device was unable to be retrieved and there was filter calcification.There have been no documented attempts to remove the filter.Additionally, the patient is reported to be suffering from pain, fear and mental anguish related to the device.Complaint conclusion: as reported, the patient underwent implantation of an optease retrievable vena cava filter for prevention of deep venous thrombosis (dvt).According to the procedural note the filter was implanted via the right internal jugular vein, with successful deployment in the infra-renal location.A central venous catheter was placed immediately following the ivc filter implant.The indication for the filter implant was bleeding, a history of dvt and abdominal pain.The device was positively identified on medical records and the device implant label.Approximately five years and fifteen days post implantation, the patient received a scan on the pelvis which noted that the filter was present in the region.As of the present, the patient is still implanted with the optease filter, which is known to be dangerous and cause serious side effects.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses.According to the patient profile form (ppf), the patient became aware approximately eight years and eight months after the implant that the filter was embedded in the wall of the inferior vena cava (ivc), embedded in other than in the wall of the ivc, that there were blood clots, clotting and/or occlusion of the ivc, the device was unable to be retrieved and there was filter calcification.There have been no documented attempts to remove the filter.The results of a computerized tomography (ct) scan of the abdomen and pelvis performed approximately eight years and eight months after the filter implant showed extensive calcifications shown within the filter.The patient appears to be draining the venous flow the lower legs through collaterals in the subcutaneous tissues of the trunk.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 optease 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.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Collateral circulation and medical device site calcification do not represent a device malfunction and may be related to underlying patient issues.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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 6894939
• MDR Text Key: 87451105
• Report Number: 1016427-2017-00616
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 18-GAUGE NEEDLE; UNKNOWN BENTSON WIRE; UNKNOWN TRIPLE LUMEN CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR