MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Embolus (1830); Occlusion (1984)

Event Date 03/18/2016

Event Type  Death  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.It was reported that a patient underwent a surgical procedure to implant an unknown vena cava filter for the treatment acute deep venous thrombosis.Additional information received per the patient profile form states that the patient experienced blood clots, clotting, post implant deep vein thrombosis and or occlusion of the inferior vena cava.The patient experienced emotional distress and anguish.The patient also experienced a weakened state from injuries and subsequently died.Information contained in the medical records indicated that the patient was implanted with an optease inferior vena cava filter for acute deep vein thrombosis of the left common femoral vein.The patient was ten days status post left craniotomy for evacuation of an epidural hematoma, with contraindication for anticoagulation.A venogram identified the renal veins, no thrombus was noted in the inferior vena cava and the filter was deployed just below the renal veins.Post implant venogram showed no clot formation and adequate placement of the filter.There were no reported complications.Past medical history is noted to include chronic respiratory failure, ventilator dependent, sepsis, ventilator associated pneumonia, previous motor vehicle accident leading to anoxic brain injury, intracranial hemorrhage and anemia.The patient¿s surgical history includes tracheostomy, peg tube placement and knee surgery.The patient resides at a long-term care facility where routine trach care was performed, hemoptysis was noted.One year and five months after the index procedure, the patient was seen in the emergency room, with a history of chronic respiratory failure on ventilator, sepsis and ventilator associated pneumonia.The patent was evaluated for the indwelling tracheostomy.The patient was admitted to the hospital with hemoptysis, fever and chronic respiratory failure on ventilator.A computed tomography (ct) was done that showed a vena cava filter in place that was most likely a trapease type filter.One year and six months after the index procedure, the patient was seen in the hospital for sepsis, related to multi-drug resistance pseudomonas and stenotrophomonas, with bilateral lower lobe pneumonia, being treated with antibiotics; however, till febrile.Acute on chronic respiratory failure with ventilator support.The patent also has anemic, history of encephalopathy and was on heparin for thrombosis prophylaxis.The physician noted that the overall prognosis was poor and was recommended to palliative and hospice care.Approximately four years after the index procedure, the patient was hospitalized for a tracheal bleed and fever.A ct scan indicated that there were no pulmonary embolisms.The scan confirmed the presence of the vena cava filter, but states that the filter is probably a trapease filter.The discharge notes states that the discharge diagnoses were ventilator associated pneumonia in the setting of chronic respiratory failure, tracheostomy on ventilator, history of seizure disorder, history of a motor vehicle accident with intracranial hemorrhage, bed-bound, dysphagia with peg tube feeding, chronic anemia and positive strep throat.The patient was discharged back to a long-term facility.There is currently no additional information available for review and an official cause of death has not been provided.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.An 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, clotting and/or occlusion of the inferior vena cava or the filter does not represent a device malfunction.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Without the procedural films or post-placement imaging and the limited information provided, the report of chronic thrombus of the inferior vena cava (ivc) filter could not be confirmed or clarified, nor can a conclusion about a relationship between the reported events and the filter be drawn.As an official cause of death has not been provided it is not possible to draw a conclusion between the filter and the event, however, given the patient¿s history there are multiple factors that may have contributed to the event.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.Please note that this is the initial/final report for this product.

Event Description

As reported by the legal team, the patient underwent a surgical procedure to implant an unknown vena cava filter for the treatment for an acute deep venous thrombosis.The device was implanted into the patient right common iliac vein.The device in the patient was positively identified by the patient's medical records.The patient is still implanted with the implanted device, which is known to be dangerous and cause serious side effects.As the result of the filter installation, the patient suffered and will be at risk of suffering from future injuries, possibly permanent arid 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 his body.Additional information received per the medical records indicate that the patient has a history of acute deep vein thrombosis of the left common femoral vein.The patient was in a motor vehicle accident.Ten days prior to the index procedure the patient had a left craniotomy for evacuation of epidural hematoma.He subsequently developed a left common femoral vein thrombosis.Since the accident, the patient has been bed bound and on a ventilator.The filter was deployed via the right common femoral vein.It was placed between the renal veins and the inferior vena cava bifurcation.Approximately four years after the index procedure, the patient was hospitalized for ventilator associated pneumonia.A computed tomography (ct) scan indicated that there were no pulmonary embolisms.The scan confirmed the presence of the vena cava filter, but states that the filter is probably a trapease filter.Additional medical records state that the patient was implanted with an optease inferior vena cava filter for acute deep vein thrombosis of the left common femoral vein.The patient was ten days status post left craniotomy for evacuation of an epidural hematoma, with contraindication for anticoagulation.A venogram identified the renal veins, no thrombus was noted in the inferior vena cava and the filter was deployed just below the renal veins.Post implant venogram showed no clot formation and adequate placement of the filter.There were no reported complications.Past medical history is noted to include chronic respiratory failure, ventilator dependent, sepsis, ventilator associated pneumonia, previous motor vehicle accident leading to anoxic brain injury, intracranial hemorrhage and anemia.The patient¿s surgical history includes tracheostomy, peg tube placement and knee surgery.The patient resides at a long term care facility where routine trach care was performed, hemoptysis was noted.One year and five months after the index procedure, the patient was seen in the emergency room, with a history of chronic respiratory failure on ventilator, sepsis and ventilator associated pneumonia.The patent was evaluated for the indwelling tracheostomy the patient was admitted to the hospital with hemoptysis, fever and chronic respiratory failure on ventilator.A computed tomography (ct) was done that showed a vena cava filter in place that was most likely a trapease type filter.The discharge note states that the discharge diagnoses were ventilator associated pneumonia in the setting of chronic respiratory failure, tracheostomy on ventilator, history of seizure disorder, history of a motor vehicle accident with intracranial hemorrhage, bed-bound, dysphagia with peg tube feeding, chronic anemia and positive strep throat.The patient was discharged to a long term facility.One year and six months after the index procedure, the patient was seen in the hospital for sepsis, related to multi-drug resistance pseudomonas and stenotrophomonas, with bilateral lower lobe pneumonia, being treated with antibiotics; however, till febrile.Acute on chronic respiratory failure with ventilator support.The patent also has anemia, history of encephalopathy and was on heparin for thrombosis prophylaxis.The physician noted that the overall prognosis was poor and was recommended to palliative and hospice care.Additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting, post implant deep vein thrombosis and or occlusion of the inferior vena cava.The patient experienced emotional distress and anguish.The patient also experienced a weakened state from injuries and subsequently died.

• Brand Name: UNKNOWN VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8340459
• MDR Text Key: 136174028
• Report Number: 1016427-2019-02512
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 GUIDE WIRE; UNKNOWN CATHETER
• Patient Outcome(s): Death
• Patient Age: 49 YR
• Patient Weight: 90