MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; THROMBECTOMY SYSTEMS

Model Number N/A

Device Problem Occlusion Within Device (1423)

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

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing telephone and fax numbers of cordis cashel are respectively, (b)(4).The product remains implanted and is thus not available for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

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 for a deep vein thrombosis (dvt).The device was implanted into the patient¿s right femoral vein.The device in the patient was positively identified by medical records.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.As the result of the trapease filter¿s 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 her body.Additional information was received from a patient profile form (ppf) that the patient has mood swings, difficulty concentrating, loss of focus, depression, anxiety due to filter implant and potential issues.A device defect, not listed, that results in more follow up care, monitoring, and treatment than normal because it is not functioning properly.The filter was inserted for deep vein thrombosis (dvt) prophylaxis due to the patient¿s morbid obesity (at least 350 pounds) with asthma and probable mobilization related to lumbosacral disk surgery.The trapease filter was deployed at the l3-l4 area in the inferior vena cava and was seated nicely.There were no procedural complications and the patient tolerated the procedure well.Additional medical records received indicate that approximately 7 years later, the patient had shortness of breath asthma.Chest radiograph showed no evidence of cardiopulmonary disease.Two weeks later, the patient had an ultrasound of the abdomen to evaluate for abdominal infection renal failure, sepsis and abdominal pain.The findings noted visualized portions of the aorta and ivc were normal.Two days later, the patient had an x-ray to evaluate for small bowel obstruction (sbo) nausea, no bowel movement and abdominal pain.The findings show the ivc filter overlies the l34.There was no evidence to suggest bowel obstruction.The patient also had a lumbar spine mri due to septic shock, acute kidney injury (aki) symptoms.The findings were minimal degenerative changes to the lumbar spine.No evidence of epidural fluid collection.4 days later, the patient had magnetic resonance imaging (mri) of the cervical spine.The indication for the procedure was persistent bilateral lower extremity motor and sensory deficits.There were mild degenerative changes of the inferior thoracic spine.No evidence of significant spinal canal or neural foraminal stenosis.No evidence of cord abnormalities.On the same day, the patient also had an mri of the lumbar spine for the same reason as the previous mri.The impression was stable appearance of the lumbar spine with degenerative disc disease at l5-s1 and mild to moderate left-sided neural foraminal stenosis at l4-l5 and l5-s1.Additional information was received from a patient profile form that there the patient has blood clots, clotting, and/or occlusion of the inferior vena cava (ivc).

Manufacturer Narrative

As reported, the patient underwent implantation of a trapease permanent inferior vena cava (ivc) filter for the treatment for a deep vein thrombosis (dvt).The filter was inserted for deep vein thrombosis (dvt) prophylaxis due to the patient¿s morbid obesity (at least 350 pounds) with asthma and probable mobilization related to lumbosacral disk surgery.The trapease filter was deployed at the l3-l4 area in the inferior vena cava and was seated nicely.There were no procedural complications and the patient tolerated the procedure well.Per the patient profile form (ppf), the patient has mood swings, difficulty concentrating, loss of focus, depression, anxiety due to filter implant and potential issues.Additional information was received from a patient profile form that there the patient has blood clots, clotting, and/or occlusion of the inferior vena cava (ivc).Additional medical records received indicate that approximately 7 years later, the patient had shortness of breath asthma.Chest radiograph showed no evidence of cardiopulmonary disease.Two weeks later, the patient had an ultrasound of the abdomen to evaluate for abdominal infection, renal failure, sepsis and abdominal pain.The findings noted visualized portions of the aorta and ivc were normal.Two days later, the patient had an x-ray to evaluate for small bowel obstruction (sbo) nausea, no bowel movement and abdominal pain.The findings show the ivc filter overlies the l3-4.There was no evidence to suggest bowel obstruction.The patient also had a lumbar spine mri due to septic shock, acute kidney injury (aki) symptoms.The findings were minimal degenerative changes to the lumbar spine.No evidence of epidural fluid collection.4 days later, the patient had magnetic resonance imaging (mri) of the cervical spine.The indication for the procedure was persistent bilateral lower extremity motor and sensory deficits.There were mild degenerative changes of the inferior thoracic spine.No evidence of significant spinal canal or neural foraminal stenosis.No evidence of cord abnormalities.On the same day, the patient also had an mri of the lumbar spine for the same reason as the previous mri.The impression was stable appearance of the lumbar spine with degenerative disc disease at l5-s1 and mild to moderate left-sided neural foraminal stenosis at l4-l5 and l5-s1.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety and mood swings do not represent a device malfunction and may be related to underlying patient related 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: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: THROMBECTOMY SYSTEMS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• MDR Report Key: 7658229
• MDR Text Key: 113010542
• Report Number: 1016427-2018-01615
• 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: other
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2009
• Device Model Number: N/A
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1006610
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/09/2018
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR