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 Vessel Or Plaque, Device Embedded In (1204); Anxiety (2328)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (15141770) 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 placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to the filter being too dangerous to remove and having to stay implanted, risking further malfunction and injury.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries, and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.According to the information received in the patient profile from (ppf), the patient became aware of the alleged events on-or-about six years and seven months post filter implantation, the patient's filter embedded in wall of the inferior vena cava (ivc) and suffer from psychological issues such as anxiety and nervousness that the filter may break loose.The following additional information received per the medical records indicate that patient underwent abdominal surgery (unknown date) and developed a deep vein thrombosis (dvt).Patient was anticoagulated.However, patient developed pulmonary embolism.Therefore, patient had a vena cava filter implantation for a pulmonary embolism after anticoagulation therapy failed.During filter implantation procedure access was gained percutaneously to the right common femoral vein.Initially, a micropuncture wire was advanced with a micropuncture sheath and then a 0.035 wire was exchanged.At that time, the trapease delivery sheath was advanced into the right common iliac vein and an inferior venacavogram was performed.Then, the sheath was advanced and the filter was deployed below the renal veins but above the vena cava bifurcation.The catheter was withdrawn.Pressure was held for 10-minutes with d-stat dry.Patient tolerated the procedure well.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to the filter being too dangerous to remove and having to stay implanted, risking further malfunction and injury.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries, and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.According to the information received in the patient profile from (ppf), the patient became aware of the alleged events on-or-about six years and seven months post filter implantation, the patient's filter embedded in wall of the inferior vena cava (ivc) and suffer from psychological issues such as anxiety and nervousness that the filter may break loose.The following additional information received per the medical records indicate that patient underwent abdominal surgery (unknown date) and developed a deep vein thrombosis (dvt).Patient was anticoagulated.However, patient developed pulmonary embolism.Therefore, patient had a vena cava filter implantation for a pulmonary embolism after anticoagulation therapy failed.During the filter implantation procedure, access was gained percutaneously to the right common femoral vein.Initially, a micropuncture wire was advanced with a micropunture sheath and then a 0.035 wire was exchanged.At that time, the trapease delivery sheath was advanced into the right common iliac vein and an inferior venacavogram was performed.Then, the sheath was advanced and the filter was deployed below the renal veins but above the vena cava bifurcation.The catheter was withdrawn.Pressure was held for 10-minutes with d-stat dry.Patient tolerated the procedure well.The product was not returned for analysis.A review of the device history record (15141770) revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The 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.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of nervousness, unease and worry.Endothelialization, remodeling/restructuring of the internal lumen of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.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.

• 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
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7544578
• MDR Text Key: 109261638
• Report Number: 1016427-2018-01487
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

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 Catalogue Number: 466P306AU
• Device Lot Number: 15141770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Disability
• Patient Age: 67 YR