MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306AU

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

Patient Problems Embolus (1830); Occlusion (1984)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot r0703589 presented no issues during the manufacturing process that can be related to the reported event.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 of blood clots.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.The following additional information received per the patient profile form (ppf) indicates that the patient is suffering from blood clots, clotting, occlusion of the inferior vena cava (ivc), mood swings, difficulty concentrating, depression, anxiety and fear.According to the information received in the medical records, the patient has a history of left lower extremity deep vein thrombosis (dvt).The indication for the filter placement was failure of anticoagulation therapy.The filter was deployed via the right femoral vein.There is no additional information available.

Manufacturer Narrative

As reported, a patient underwent a placement of a trapease permanent vena cava filter.The information provided indicated that there are blood clots, clotting and occlusion of the inferior vena cava (ivc), the patient is also reported to be experiencing mood swings, difficulty concentrating, depression, anxiety and fear.The device in the patient was positively identified by medical records and as of the present, the patient is still implanted with the device.The indication for the filter placement was failure of anticoagulation therapy.The filter was deployed via the right femoral vein.There is currently no additional information available for review.The product was not returned for analysis.A review of the device history record dhr) associated with lot r0703589 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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 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 depression 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7574597
• MDR Text Key: 110272333
• Report Number: 1016427-2018-01522
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2006
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0703589
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 35 YR