MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE FILTER; THROMBECTOMY SYSTEMS (DQO)

Catalog Number 466P306X

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: as reported in the publication by nagarsheth, et al catheter-directed therapy is safe and effective for the management of acute inferior vena cava thrombosis; annals of vascular surgery (2015); 1373-1379; all 12 patients who had a trapease filter experienced acute ivc (inferior vena cava) filter thrombosis.All patients were treated under conscious sedation and local anesthesia.Imaging of the access site was performed at the start of the procedure by dus imaging, and access was obtained via the common femoral, popliteal, or internal jugular vein by ultrasound-guided puncture depending on physician preference.Occluded ivc filters were traversed using a.035-in guide-wire.When a severely occluded ivc filter had extension of thrombus into both common iliac veins, bilateral wire access was obtained to perform dual-catheter pmt/cdt.This provided a more substantial flow lumen within the ivc and iliac veins.Pmt (angiojet/trellis) was performed within the occluded filter based on thrombus burden and symptomatology.After the intervention, all patients were continued on medical therapy consisting of therapeutic anticoagulation with heparin (18 u/kg) or enoxaparin sodium (1 mg/kg every 12 hr) followed by oral anticoagulation therapy for a period of 6 months.Patients who had a prior episode of vte were kept on lifelong anticoagulation.The products were not returned for analysis.A review of the manufacturing records could not be conducted without a lot number.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.Thrombus in the filter does not represent a device malfunction.Thrombosis in the filter is a well-known potential complication and occurs in approximately 3.6 to 11.2 % of all patients¿.Factors that may have influenced the event include patient, pharmacological and lesion.Thrombosis in the filter is a well-known potential complication and occurs in approximately 3.6 to 11.2 % of all patients.Factors that may have influenced the events include patient, pharmacological and lesion.There is no medical evidence of a causal relationship between the vena cava filter and the formation the thromboses.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore no corrective and preventive actions will be taken at this time.Please note the attached literature article.Literature citation: nagarsheth et al.(2015).Catheter-directed therapy is safe and effective for the management of acute inferior vena cava thrombosis.Annals of vascular surgery, 1373-1379.Please note that this mdr report is being submitted for multiple patients with no specific product information or patient information available.Concomitant products: heparin (18 u/kg) or enoxaparin sodium (1 mg/kg every 12 hr), infusion therapy (18 u/kg), followed by oral anticoagulation therapy for a period of 6 months.Patients who had a prior episode of vte were kept on lifelong anticoagulation.0.035-in unk guide wire.This mdr is related to mdr report#¿s: 9616099-2015-00596, 9616099-2015-00595, 9616099-2015-00594, 9616099-2015-00593, 9616099-2015-00592, 9616099-2015-00591, 9616099-2015-00590, 9616099-2015-00597, 9616099-2015-00589, 9616099-2015-00587, 9616099-2015-00586, 9616099-2015-00585.

Event Description

As reported in the publication by nagarsheth, et al catheter-directed therapy is safe and effective for the management of acute inferior vena cava thrombosis; annals of vascular surgery (2015); 1373-1379; all 12 patients who had a trapease filter experienced acute ivc (inferior vena cava) filter thrombosis.All patients were treated under conscious sedation and local anesthesia.Imaging of the access site was performed at the start of the procedure by dus imaging, and access was obtained via the common femoral, popliteal, or internal jugular vein by ultrasound-guided puncture depending on physician preference.Occluded ivc filters were traversed using a.035-in guide-wire.When a severely occluded ivc filter had extension of thrombus into both common iliac veins, bilateral wire access was obtained to perform dual-catheter pmt/cdt.This provided a more substantial flow lumen within the ivc and iliac veins.Pmt (angiojet/trellis) was performed within the occluded filter based on thrombus burden and symptomatology.After the intervention, all patients were continued on medical therapy consisting of therapeutic anticoagulation with heparin (18 u/kg) or enoxaparin sodium (1 mg/kg every 12 hr) followed by oral anticoagulation therapy for a period of 6 months.Patients who had a prior episode of vte were kept on lifelong anticoagulation.

• Brand Name: TRAPEASE FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DQO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5242706
• MDR Text Key: 31827519
• Report Number: 9616099-2015-00592
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/12/2015

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 Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention