MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

The catalog and lot numbers are not known.The exact event date is not known.As reported, the patient underwent placement of the trapease vena cava filter.The indication for the filter placement was not reported.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to: an attempted retrieval of filter through simultaneous right internal jugular and femoral approach complicated by vascular injury, prompting abortion of the procedure.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.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined.The attempted retrieval date is unknown at this time.The trapease vena cava filter is designed for permanent implantation.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as twelve days.The brief also reported vascular injury during the attempted retrieval of the filter.However, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Given the limited information 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.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to: an attempted retrieval of filter through simultaneous right internal jugular and femoral approach complicated by vascular injury, prompting abortion of the procedure.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.

Manufacturer Narrative

Correction to product code.

Manufacturer Narrative

Corrected data: product code.

Manufacturer Narrative

Complaint conclusion being updated with new information received: addition of ln; addition of anxiety, see ncr for potassium deficiency.As reported, the patient underwent placement of the trapease vena cava filter.The patient is reported to have a previous medical history that included factor v leiden mutation and recurrent deep vein thrombosis (dvt) and pulmonary embolism (pe) despite systemic anticoagulation.The trapease filter was deployed in the infrarenal inferior vena cava (ivc) via the right common femoral vein.The patient is reported to have tolerated the procedure well.Approximately thirteen years and eight months after the implantation, the patient underwent planned retrieval of the ivc filter.Attempts to remove the filter through simultaneous right internal jugular and femoral vein approach were complicated by inability to collapse the filter and by vascular injury.The patient is reported to have become diaphoretic and hypotensive.The injury was treated with balloon insufflation and with subsequent abortion of the procedure.The patient reported having become anemic after this procedure and reports being fearful for what could happen in the future with regards 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 vena cava filter is indicated for use in the prevention of recurrent pe via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined.Filter retrieval was attempted more than thirteen years after its¿ implantation.The trapease vena cava filter is designed for permanent implantation.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as twelve days.The brief also reported vascular injury during the attempted retrieval of the filter.However, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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, but not limited to, nervousness, unease and worry.Given the limited information 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.

Manufacturer Narrative

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to: an attempted retrieval of filter through simultaneous right internal jugular and femoral approach complicated by vascular injury, prompting abortion of the procedure.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 events approximately thirteen years and eight months post implantation.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, device unable to be retrieved.An attempted but unsuccessful percutaneous removal procedure was performed thirteen years and eight months post implantation.The patient reports they became anemic after the failed attempt to remove the filter.The patient states they suffered from low potassium which caused severe pain and cramping.The patient is fearful for what could happen in the future regarding the device.The following additional information received per the medical records stat that that the patient has a history of factor v leiden mutation, recurrent dvt, and recurrent pulmonary embolism.During the implant procedure, the right common femoral and caudal external iliac veins were accessed.A 5 french micropuncture system.The system was exchanged for the introducing sheath and the filter was then deployed in the infrarenal inferior vena cava.The patient tolerated the procedure well.During the explant procedure, a catheter was inserted into the ivc and attempts were made to collapse the filter from the neck and femoral approach.The patient became diaphoretic and hypotensive, and a decision was made to terminate the procedure.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8125346
• MDR Text Key: 129067218
• Report Number: 1016427-2018-02348
• Device Sequence Number: 0
• Product Code: DTK
• 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,Followup,Followup,Followup
• Report Date: 06/10/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5 FRENCH MICROPUNCTURE
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR