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

Model Number 466P306X

Device Problems Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment of deep venous thrombosis (dvt).The device was implanted into the patient¿s right femoral vein region at the l2-l3 level.The device in the patient was positively identified by medical records.On or about seven years four months and twenty-four days post implantation of the device, the patient received a scan on his right lower extremity after complaints of pain in the region of his inferior vena cava (ivc) filter.The patient was diagnosed with acute partial deep venous thrombosis (dvt) involving the right popliteal vein.On or about one month and eleven days later, the patient had a follow up checkup for pain, was treated for pulmonary hypertension and had to have a cauterization of his heart.The patient is currently on coumadin therapy.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 (dhr) 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.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.Pain does not represent a device malfunction.Pulmonary hypertension is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart.Pulmonary hypertension also does not represent a device malfunction.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation 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.

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 venous thrombosis (dvt).The device was implanted into the patient¿s right femoral vein region at the l2-l3 level.The device in the patient was positively identified by medical records.On or about seven years and four months after the procedure, the patient received a scan on his right lower extremity after complaints of pain in the region of his inferior vena cava (ivc) filter.The patient was diagnosed with acute partial deep venous thrombosis (dvt) involving the right popliteal vein.On or about one month and eleven days later, the patient had a follow up checkup for pains and was treated for pulmonary hypertension and had to have a cauterization of his heart.The patient is currently on coumadin therapy.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.

Manufacturer Narrative

According to the patient profile form (ppf) the device was implanted into the patient¿s right femoral vein region at the l2-l3 level.According to the patient profile form (ppf) there is tilt of the filter and perforation of filter struts outside of the ivc.The patient also reports to be suffering from mental anguish related to the filter.Complaint conclusion: it was reported that a patient underwent placement of a trapease permanent vena cava filter.The information provided indicated that there is tilt of the filter and perforation of the filter struts outside the of the inferior vena cava (ivc).The patient has also experienced pulmonary hypertension post implant and deep vein thrombosis (dvt).The indication for the device implant was dvt.The filter was implanted via the patient¿s right femoral vein and deployed in the region of the l2-l3 vertebral level.There were no reported complications associated with the implant of the device.On or about seven years and four months after the procedure, the patient received a scan on his right lower extremity after complaints of pain in the region of his inferior vena cava (ivc) filter.The patient was diagnosed with acute partial deep venous thrombosis (dvt) involving the right popliteal vein.On or about one month and eleven days later, the patient had a follow up checkup for pains and was treated for pulmonary hypertension and had to have a cauterization of his heart.The patient is currently on coumadin therapy.According to the patient profile form (ppf) there is tilt of the filter and perforation of filter struts outside of the ivc.The patient also reports to be suffering from mental anguish related to the filter.The patient¿s medical history has not been provided and there is currently no additional information available.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.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt and perforation of the ivc could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn.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.Following this period of time, 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.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.Anxiety, pulmonary hypertension and pain do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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: 6893261
• MDR Text Key: 87325276
• Report Number: 1016427-2017-00614
• 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: 03/28/2018

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 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: 01/31/2018
• Supplement Dates FDA Received: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER; UNKNOWN DILATOR; UNKNOWN WIRE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 64 YR