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

Catalog Number 466P306X

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is a trapease vena cava filter and for which the catalog and lot numbers are not currently available.Therefore expiration date is unknown., if obtained, a follow up report will be submitted within 30 days upon receipt.Please note that patient codes for blood clots for venous insufficiency could not be found.As reported in the legal brief lenard vs.Cordis, the plaintiff underwent placement of a trapease vena cava filter which subsequently malfunctioned and caused injury and damages to plaintiff including, but not limited to, blood clots, clotting and occlusion of ivc filter, resulting venous insufficiency and venous ulcers.As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The trapease 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 thrombosis within the filter does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.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.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds.The skin of the lower legs can become thick, dry, and fragile.This may lead to ulceration of the skin - usually on the inside aspect of the leg just above the ankle.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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.

Event Description

As reported in the legal brief (b)(6), the plaintiff underwent placement of a trapease vena cava filter which subsequently malfunctioned and caused injury and damages to plaintiff including, but not limited to, blood clots, clotting and occlusion of ivc filter, resulting venous insufficiency and venous ulcers.As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.

• 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: 5920848
• MDR Text Key: 53691405
• Report Number: 9616099-2016-00577
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2016

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: Lay User/Patient
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1