MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problems Difficult to Remove (1528); Retraction Problem (1536)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100)

Event Date 07/01/2014

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of the trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, ivc filter collapsed and can no longer be retrieved.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.There is currently no additional information available for review.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 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.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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 information provided indicated that the filter collapsed.Without the procedural films and/or post-implant imaging available for review, the reported event could not be confirmed or further clarified, nor a cause or contributing factors be established.With the limited information provided it is not possible to establish a relationship between the reported events and the device.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal team, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, ivc filter collapsed and can no longer be retrieved.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.

Event Description

According to the information received in the patient profile from (ppf), the patient became aware of the events thirteen years and eleven months post implantation.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, unable to be retrieved.A unsuccessful retrieval attempt was made thirteen years post implantation.The filter was moved aside for stent placement.The patient also reports fear and anxiety.

Manufacturer Narrative

Information is pending and will be submitted in a follow up report when received.

Manufacturer Narrative

According to the information received in additional patient profile from (ppf), the patient became aware of the events twelve years and six months post implantation.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting, and/or occlusion of the ivc, and chronic dvt.The trapease filter was visualized in the ivc and scans revealed collapse/decompression of the ivc below the level of the filter.An inferior venacavogram performed twelve years post implant demonstrated severely restricted flow through the indwelling trapease filter in the ivc from the right lower extremity.The patient then underwent stenting of the ivc filter and common iliac veins.The patient suffers from constant worry and anxiety about the state of her health related to the filter.

Manufacturer Narrative

It was reported that a patient underwent placement of the trapease vena cava filter.The information provided indicated that the filter malfunctioned and collapsed and can no longer be retrieved.The information provided indicated that the filter cannot be retrieved, there are blood clots, clotting and/or occlusion of the inferior vena cava (ivc).The patient also reports to have experienced anxiety and fear.The indication for the filter placement has not been provided.Initial radiology impression notes, post implant, indicated that there was no evidence of thrombus within the proximal right external iliac, right common iliac veins and the ivc at the time of or post placement.The filter was successfully deployed within the infrarenal ivc.Approximately twelve years and six months post implant the patient presented to the hospital and was found to have extensive chronic occlusion of the ivc, bilateral common iliac veins and chronic deep vein thrombosis (dvt).According to the information provided the filter was visualized in the ivc and scans revealed collapse/decompression of the ivc below the level of the filter.Approximately three months later an inferior venacavogram demonstrated severely restricted flow through the indwelling filter in the ivc from the right lower extremity.The patient underwent stenting of the filter and the common iliac veins.According to the information provided, the patient underwent an unknown and unsuccessful procedure to attempt removal of the filter approximately thirteen years post implant.The patient initially reported that no retrieval attempt had been made.There is currently no additional information available for review.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 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.Following implant, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts, making retrieval difficult.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.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.The inferior vena cava filter is not indicated for use in the prevention of deep vein thrombosis.Without imaging or medical records available for review the reported events could not be confirmed or further clarified.It is not customary practice to attempt to remove a filter that has been stented.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.A device malfunction has not been reported at this time.A device malfunction has not been reported at this time.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Manufacturer Narrative

Upon review, the following section has been corrected: product code.

• Brand Name: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 7733396
• MDR Text Key: 115523019
• Report Number: 1016427-2018-01709
• Device Sequence Number: 1
• 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: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 70 YR