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

Catalog Number 466F230AJ

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

Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown.The patient experienced clot in filter, post-thrombotic syndrome, caval thrombosis, failed removal due to tilting and embedment of filter.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for filter placement is not available.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to clot in filter, post-thrombotic syndrome, caval thrombosis, failed removal due to tilting and embedment of filter.The filter remains implanted; thus, unavailable for analysis.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 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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's 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 12 days.Blood clots, post thrombotic syndrome and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, 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.Please note that this is the initial/final report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of an 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 clot in filter, post-thrombotic syndrome, caval thrombosis, failed removal due to tilting and embedment of filter.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 sectionsage or date of birth, date of event, event, other relevant history, pma/510k, type of reportable event, and if follow-up, what type have been updated accordingly.Section b5: additional information received per the medical records indicate that the patient had the filter implanted after a motor vehicle accident were he had a pulmonary embolism.Ten weeks after the index procedure there was an attempt to remove the filter.It was found that the filter was tilted, there was a small clot within the filter, there were no other caval of right iliac thrombus.During the procedure the patient formed a moderate sized thrombus within the filter.The procedure was aborted.The patient tolerated the procedure well.Four days later, there was a second attempt to remove the filter.After multiple attempts, the filter could not be engaged.An angiogram was performed demonstration the formation of a large thrombus within the filter.The procedure was terminated.It was noted that the patient had experienced weakness in their left leg.  additional information received per the patient profile form (ppf) states that the patient has also experienced blood clots, clotting and occlusion of the inferior vena cava.The patient continues to experience sleeplessness.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

As reported, the patient had placement of an optease inferior vena cava (ivc) filter.Per the medical records, the patient had had a pulmonary embolism post mva.The filter was deployed via the right internal jugular vein.It was placed at the l2 level.The patient was in stable condition after the procedure.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to clot in filter, post-thrombotic syndrome, caval thrombosis, failed removal due to tilting and embedment of filter.Ten weeks after the index procedure there was an attempt to remove the filter.It was found that the filter was tilted, there was a small clot within the filter, there were no other caval of right iliac thrombus.During the procedure the patient formed a moderate sized thrombus within the filter.The procedure was aborted.Four days later, there was a second attempt to remove the filter.After multiple attempts, the filter could not be engaged.An angiogram was performed demonstration the formation of a large thrombus within the filter.The procedure was terminated.It was noted that the patient had experienced weakness in their left leg.Additional information received per the patient profile form (ppf) states that the patient has also experienced blood clots, clotting and occlusion of the inferior vena cava and sleeplessness.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 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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's 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 12 days.Blood clots, post thrombotic syndrome and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Sleepless ness and weakness do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, 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, g3, g6, h1, h2 and h6.As reported a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused clot in filter, post-thrombotic syndrome, caval thrombosis, failed removal due to tilting and embedment of filter.The patient reported becoming aware of the events approximately ten weeks post implant when an unsuccessful percutaneous retrieval attempt was made.A second retrieval attempt was made four days later.The patient also reported sleeplessness related to the filter.According to the implant record the indication for the filter implant was pulmonary embolism after a motor vehicle accident.The patient was negative for deep vain thrombosis.The filter was placed via the right internal jugular vein and deployed at the l2 level.Ten weeks post implant there was an attempt to remove the filter.It was found that the filter was tilted, there was a small clot within the filter, there were no other caval or right iliac thrombus.During the procedure the patient formed a moderate sized thrombus within the filter.The procedure was aborted.The patient tolerated the procedure well.Four days later, there was a second attempt to remove the filter.After multiple attempts, the filter could not be engaged.An angiogram was performed demonstrating the formation of a large thrombus within the filter.The procedure was terminated.It was noted that the patient had experienced weakness in the left leg.The patient subsequently reported perforation of filter struts outside the inferior vena cava (ivc).The patient became aware of the reported event approximately ten weeks post implant.The product remains implant and therefore not available 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.Blood clots, clotting and/or occlusion do not indicate a device malfunction.Rather, patient, pharmacological factors vessel characteristics may have contributed to these events.Post-thrombotic syndrome (pts) is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis (blood clot) in the leg.Pts symptoms include chronic leg pain, swelling, redness, and ulcers (sores).Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implant.Usage of the product other than that indicated in the product's 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 explant problems after as short a period as 12 days.Sleepless ness and weakness do not represent a device malfunction and may be related to underlying patient related issues.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.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, 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.In addition to the previously reported events the form states that the patient also experienced perforation of filter struts outside the inferior vena cava (ivc).The patient became aware of the reported events approximately ten weeks after the index procedure.

• Brand Name: JUGULAR 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: 8104030
• MDR Text Key: 128387782
• Report Number: 1016427-2018-02308
• 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,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 466F230AJ
• Device Lot Number: 17582355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6-FRENCH SHEATH; UNKNOWN 0.035 GUIDE WIRE
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 45 YR
• Patient Sex: Male