MAUDE Adverse Event Report: CORDIS CASHEL FEMORAL 55CM KIT; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466F230AF

Device Problems Difficult to Remove (1528); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolus (1830); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.As reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter had tilted, become embedded and was associated with blood clots and caval thrombosis.In addition, the patient indicated that the filter could not be retrieved after multiple attempts.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 optease retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (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 images or procedural films for review, the reported filter tilt and retrieval difficulty events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.Without procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease retrievable vena cava filter is indicated up to 23 days post implantation.Usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling.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.Blood clots and thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.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 brief, the patient underwent placement of a optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to blood clots, caval thrombosis, filter tilt, embedment and multiple failed removals.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

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b7, g3, g4, g7, h1, h2 and h6.Section b5: additional information received per the medical records indicate that the patient had an immediate history of extensive deep vein thrombosis (dvt) in the right lower extremity with pulmonary emboli and worsening symptoms while on anticoagulation therapy.The dvt involved the superficial femoral, common femoral and entire iliac venous system.The patient also had a history of end stage renal disease.  the filter was deployed via the left common femoral vein.There appeared to be some filling defect in the inferior vena cava (ivc).A venacavogram was obtained which revealed a filling defect in the left lateral portion of the filter.There was flow through the filter.It was thought to not be prudent to attempt removal since there appears to be a thrombus in the filter itself.The filter was left in place.The patient tolerated the procedure well.Seven months after the index procedure there was a second attempt to remove the filter.Despite using multiple shaped catheters, the hook could not be engaged.  additional information received per the patient profile form (ppf) states that the patient experienced tilting of the filter, filter embedded other than in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc.The form also states that the device was unable to be retrieved.There were two unsuccessful removal attempts.The first attempt was four months after implantation.The second attempt was seven months after implantation.It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused blood clots, caval thrombosis, filter tilt, embedment and multiple failed removals.The patient reported experiencing tilt, filter embedded, blood clots, clotting and/or occlusion of the inferior vena cava (ivc) and two failed removal attempts, at four months and seven months post implant, respecitvely.The indication for the filter implant was extensive deep vein thrombosis (dvt) of the right lower extremity (rle) with pulmonary emboli and worsening symptoms on anticoagulation.The patient was also noted to have end stage renal disease.The filter was place via the left common femoral vein; the exact deployment of the filter is unknown as the remainder of the operative note was not provided.Additional intervention performed at the time of the filter placement was reported as sheath placement in the right popliteal vein, thrombolysis of the right lower extremity, mechanical thrombectomy of thrombus in the rle, right iliac venous angioplasty, mechanical thrombectomy with angiojet and arterial venous fistula ligation.Findings noted during the procedure were extensive thrombosis of the superficial femoral, common femoral and entire iliac venous system in the right lower extremity.Approximately four months later the patient underwent a procedure to remove the filter.The indication for the procedure was deep vein thrombosis of the ivc filter.Findings noted that there were filling defect in the left lateral portion of the ivc filter, that appeared to be thrombus, although there was flow through the filter.With the finding it was though imprudent to attempt removal of the filter.Approximately seven months post implant a second attempt was made to remove the filter.An inferior venocavogram was performed and noted that the ivc and the filter were widely patent.Multiple attempts were made to snare the hook of the filter, but the hook could not be engaged.The hook on the filter appeared to be against the wall of the ivc.Despite multiple shaped catheters the hook could not be engaged, and the procedure was discontinued.There is currently no additional information available for review.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 optease 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 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.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.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.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.Without images for review, the reported filter tilt could not be confirmed, and the exact causes could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.This event does not represent a malfunction of the device.With the limited information provided a causal relationship between the filter and the reported events could not be established.There is nothing to suggest that the reported events are 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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, b5, d1, d4, g2, g3, g6, h1, h2, h4 and h6.It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused blood clots, caval thrombosis, filter tilt, embedment and multiple failed removals.The patient reported experiencing tilt, filter embedded, blood clots, clotting and/or occlusion of the inferior vena cava (ivc) and two failed removal attempts, at four months and seven months post implant, respectively.The indication for the filter implant was extensive deep vein thrombosis (dvt) of the right lower extremity (rle) with pulmonary emboli and worsening symptoms on anticoagulation.The patient was also noted to have end stage renal disease.The filter was place via the left common femoral vein; the exact deployment of the filter is unknown as the remainder of the operative note was not provided.Additional intervention performed at the time of the filter placement was reported as sheath placement in the right popliteal vein, thrombolysis of the right lower extremity, mechanical thrombectomy of thrombus in the rle, right iliac venous angioplasty, mechanical thrombectomy with angiojet and arterial venous fistula ligation.Findings noted during the procedure were extensive thrombosis of the superficial femoral, common femoral and entire iliac venous system in the right lower extremity.Approximately four months later the patient underwent a procedure to remove the filter.The indication for the procedure was deep vein thrombosis of the ivc filter.Findings noted that there were filling defects in the left lateral portion of the ivc filter, that appeared to be thrombus, although there was flow through the filter.With the finding it was though imprudent to attempt removal of the filter.Approximately seven months post implant a second attempt was made to remove the filter.An inferior venocavogram was performed and noted that the ivc and the filter were widely patent.Multiple attempts were made to snare the hook of the filter, but the hook could not be engaged.The hook on the filter appeared to be against the wall of the ivc.Despite multiple shaped catheters the hook could not be engaged, and the procedure was discontinued.The patient subsequently reported becoming aware of perforation of filter struts outside the ivc, approximately four months post implant.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 optease 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 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.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.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.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the events.Without images available for review the reported events could not be confirmed or further clarified.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.With the limited information provided a causal relationship between the filter and the reported events could not be established.There is nothing to suggest that the reported events are 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.

Event Description

An amended patient profile form (ppf) was received which states that in addition to the previously reported events, the patient also experienced perforation of filter struts outside the inferior vena cava (ivc).The patient became aware of this reported event approximately four months after the index procedure.

• Brand Name: FEMORAL 55CM KIT
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• 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 ; 7863138372
• MDR Report Key: 9484940
• MDR Text Key: 177009402
• Report Number: 1016427-2019-03680
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 466F230AF
• Device Lot Number: 17423568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 22 YR
• Patient Sex: Female