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

Catalog Number 466P306AU

Device Problems Occlusion Within Device (1423); Improper or Incorrect Procedure or Method (2017)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombosis (2100); Anxiety (2328)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days of this report.

Event Description

As reported in the legal brief, the patient underwent placement of a trapeasetm permanent vena cava filter.The following additional information received per the patient profile form (ppf) indicates the device was implanted due to recurrent left lower extremity deep venous thrombosis and noncompliance on anticoagulation.The patient is reported to have experienced occlusion of the filter that required the placement of a second filter approximately six years after the index procedure.Medical records for this procedure were not provided.The patient is reported to continue to experience anxiety related to the device.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.It was reported that a patient underwent placement of a trapease permanent vena cava filter.The indication for the implant was recurrent left lower extremity deep vein thrombosis (dvt) in a patient that was noncompliant with anticoagulation therapy.The device was implanted via the right common femoral vein at the level of l2-l3 interspace.Venogram performed at the time revealed a widely patent inferior vena cava (ivc) and the renal vessels coming off at the proximal portion of the body of l2.The procedure was completed without complications.Additional information contained in the patient profile form (ppf) indicated that the patient is reported to have experienced clotting, occlusion of the ivc, device unable to be retrieved, and occlusion of the filter that required the placement of a second filter approximately six years after the index procedure.Medical records for the additional procedure was not provided.The patient is reported to continue to experience anxiety related to the device.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.Clotting, deep vein thrombosis, and device occlusion related to clotting, and embedded in the wall 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 a device malfunction could be confirmed.The reported information indicates that the patient is experiencing anxiety.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to determine a relationship between the reported events and the device.Review of the available information does not suggest that there is 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: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CORPORATION; cordis cashel; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7170817
• MDR Text Key: 96583384
• Report Number: 1016427-2018-00969
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2018
• 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: R0907483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 54 YR