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

Model Number 466P306X

Device Problem Defective Device (2588)

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

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

According to the information received in the patient profile from (ppf), 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.The patient suffers from pain, and fear that the implant has moved or might cause further injury or death.The following additional information received per the medical records state that the patient has a history of right lower extremity dvt with poor response to anticoagulation therapy.The patient also has a history of diabetes, congestive heart failure, hypothyroidism, hypertension and asthma.During the implant procedure, the left common femoral vein was accessed and a vascular sheath was inserted.The ivc filter was deployed to the two-three interface.The patient tolerated the procedure well.Information is pending and will be submitted in a follow up report when received.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter for the treatment for a deep vein thrombosis.That filter is still in place, which is known to be dangerous and cause serious side effects.As a result of the filter installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring 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, not limited to the apprehension and risk associated with retaining a defective device inside the body.According to the information received in the patient profile from (ppf), 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.The patient suffers from pain, and fear that the implant has moved or might cause further injury or death.The following additional information received per the medical records state that the patient has a history of right lower extremity dvt with poor response to anticoagulation therapy.The patient also has a history of diabetes, congestive heart failure, hypothyroidism, hypertension and asthma.During the implant procedure, the left common femoral vein was accessed and a vascular sheath was inserted.The ivc filter was deployed to the two-three interface.The patient tolerated the procedure well.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the patient experienced blood clots, clotting, and/or occlusion of the inferior vena cava (ivc), after implant.The patient also reports to have experienced pain, and fear that the implant has moved or might cause further injury or death.The patient¿s medical history is significant for deep vein thrombosis (dvt) diabetes, congestive heart failure, hypothyroidism and asthma.The patient presented to the emergency room with complaints of chest pain, over the past few days, as well as some lower leg pain and swelling.Further evaluation determined that the patient had a pulmonary embolism (pe) and was started on heparin.The patient, however, reported having large amounts of blood in toilet after having a bowel movement.The patient also has a history of hemorrhoids.The patient remained on heparin and underwent a colonoscopy which was negative for polyps or any source of gastro-intestinal bleeding.Due to the patient¿ s history of two dvt¿s and pe, it was decided to implant a vena cava filter.The filter was placed via the left common femoral vein and deployed at the level two-three interface.The patient tolerated the procedural well with no reported complications.The medical records also note that it was difficult to get the patient¿s international normalized ration (inr) increased and was only reached after twenty-two milligrams of coumadin was given daily.Later, during the hospitalization the patient complained of abdominal pain, work up revealed hypocalcemia, an ultrasound and computed tomography scan of the abdomen were negative.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 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, clotting, and device occlusion related to clotting do not indicate a device malfunction.Without imaging or medical records available for review the report of blood clots, clotting and/or occlusion of the ivc could not be confirmed or clarified, nor can a conclusion about a relationship between the reported event and the filter be drawn.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.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.Anxiety and pain do not represent a device malfunction and may be related to underlying patient specific issues.A device malfunction has not been reported at this time.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such 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: 8201333
• MDR Text Key: 131585124
• Report Number: 1016427-2018-02369
• Device Sequence Number: 0
• Product Code: DTK
• 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
• Report Date: 01/29/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• 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
• Date Manufacturer Received: 12/30/2018
• Patient Sequence Number: 1
• Patient Age: 63 YR