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); Swelling (2091)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent placement of defendants trapease vena cava filter.That filter is still in place, and recent studies confirm the filter now presents more risks than benefits, including an increased risk of forming a blood clot.The extent of the device failure has not been fully documented by the patients treating medical provider(s).As a result of the malfunction, the patient has or may suffer life-threatening injuries and damages and require extensive medical care and treatment the patient has or may suffer and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.The patient will require continued close monitoring of the filter, medications to reduce the risks of new blood clots, and may need a risky surgery to attempt to remove the filter.Additional information was received from a patient profile form which indicated that there are blood clots, clotting, and/or occlusion of the inferior vena cava (ivc), the device is unable to be retrieved because the filter is in place more than 90 days, too risky to attempt retrieval and future perforation and fracture are likely.There have been no removal attempts made.The patient has leg swelling, fear of future blood clots, mental anguish and loss of sleep due to fear that the filter will break off.At filter placement, the preoperative diagnosis was recurrent pulmonary emboli.The inferior vena cava filter was deployed at the l2-3 interspace, more over the l2 vertebral body with the inferior portion of the filter over the interspace.Access was via the right femoral vein.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter is still in place and the extent of the device failure has not been fully documented by the patients treating medical provider(s).Information provided on the patient profile form indicated that there have been blood clots, clotting, and/or occlusion of the inferior vena cava (ivc), the device is unable to be retrieved because the filter is in place more than 90 days, too risky to attempt retrieval and future perforation and fracture are likely.There have been no removal attempts made.The patient has leg swelling, fear of future blood clots, mental anguish and loss of sleep due to fear that the filter will break off.The indication for the filter was recurrent pulmonary emboli (pe).The filter was placed via the right femoral vein and deployed at the l2-3 interspace, more over the l2 vertebral body with the inferior portion of the filter over the interspace.The patient tolerated the procedure well and was transported to the recovery room in stable condition.The patient¿s medical history procedural imaging have not been provided and there is currently no additional information available for review.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 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.Without films of the index procedure or post implant imaging, the reported caval thrombosis and retrieval difficulty could not be confirmed or further clarified at this time.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could not be confirmed.Anxiety and leg swelling do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Given the limited information currently available for review, there is nothing to suggest that a malfunction in 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
• Manufacturer (Section G): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7527229
• MDR Text Key: 108722224
• Report Number: 1016427-2018-01465
• 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,Followup
• Report Date: 06/04/2018

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 Model Number: N/A
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15278754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/20/2018
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 49 YR