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

Model Number 466FXXXX

Device Problems Complete Blockage (1094); Difficult to Remove (1528)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Vascular System (Circulation), Impaired (2572)

Event Date 07/20/2017

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.

Event Description

As reported by the legal brief, the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, two failed retrieval attempts.The first retrieval attempt was a routine removal in which the filter had become tilted and embedded in the vena cava wall.The second retrieval attempt was a complex percutaneous using a dual approach; however, the filter hook was embedded in the vena cava wall.Additional evidence shows that the patient now suffers chronic filter occlusion and has been diagnosed with post-thrombotic syndrome.The patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further and proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering, and other damages.

Manufacturer Narrative

As reported, the patient had implant of a cordis ivc filter.The filter remains implanted; thus, unavailable for analysis.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, two failed retrieval attempts.The first retrieval attempt was a routine removal in which the filter had become tilted and embedded in the vena cava wall.The second retrieval attempt was a complex percutaneous using a dual approach, however, the filter hook was embedded in the vena cava wall.Additional evidence shows that the patient now suffers chronic filter occlusion and has been diagnosed with post-thrombotic syndrome.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 cordis vena cava filters are 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.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

As reported, the patient underwent implant of an optease vena cava filter.The information provided indicated that the filter subsequently tilted, there were two failed retrieval attempts, the filter is embedded in wall of the ivc, the patient experienced blood clots, clotting, and/or occlusion of the ivc, chest pain, shortness of breath, and collateral vessels due to chronic occlusion of the filter.The first retrieval attempt was a routine removal in which the filter had become tilted and embedded in the vena cava wall.The second retrieval attempt was a complex percutaneous using a dual approach, however, the filter hook was embedded in the vena cava wall.The information provided also stated that the patient now has chronic filter occlusion and has been diagnosed with post-thrombotic syndrome.The medical records state the patient has a history of tobacco use and protein c deficiency.The indication for the filter implant was a patient with protein c deficiency who develops persistent deep vein thrombosis despite being on coumadin.The filter was placed via the right femoral vein and deployed with preservation of the renal veins.The patient underwent first failed standard percutaneous removal three months and two days post implant in which the hook was noted to be embedded in the caval wall and the procedure was abandoned after multiple attempts to snare the hook were unsuccessful.A venogram confirmed that there was no thrombus within the filter.The patient underwent a second percutaneous attempt to remove the filter approximately two months later.According to the procedural notes, the hook would not enter the sheath and only moved around behind the sheath.After two hours of attempting to remove the hook, the procedure was ended.The patient indicated that the doctor attempted to snag the hook with a catheter wire and after multiple attempts, including the use of a laser sheath, the procedure was abandoned.According to the procedural notes, a laser sheath was not used.A final venography showed the filter with no evidence of clot or filter fracture.The venography did reveal that half of the filter was either embedded within the wall of the ivc or covered with neointima.The operative conclusion notes indicated that this was a patient with an ivc filter placed several months ago, which is now embedded in the wall of the ivc, with 2 failed retrieval attempts.The filter is open, and the patient is on chronic anticoagulation and the recommendation would be to not proceed with a surgical removal of the filter.The patient submitted to a computed tomography (ct) scan the day following the second removal attempt.The report revealed collateral vessel in the pelvis and chronic occlusion of left common iliac vein.The patient again submitted to an ultrasound a month later in which the report revealed a non-occlusive thrombus in the right popliteal vein that was suspect to being chronic.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 cordis vena cava filters are 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.Collateral circulation is the circulation of blood established through enlargement of minor vessels and anastomosis of vessels with those adjacent parts when a major vein or artery is functionally impaired.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.Chest pain and shortness of breath do not represent a device malfunction and may be related to underlying patient specific issues.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

According to the information received in the patient profile from (ppf), the patient became aware of the events four months and three days post implantation.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt, embedded in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc, device unable to be retrieved, and collateral vessels due to chronic occlusion of the filter.Two unsuccessful percutaneous removal procedures were attempted.The patient underwent first failed standard percutaneous removal three months and two days post implantation in which the hook was tilted and embedded in the caval wall and the procedure was abandoned after multiple attempts to snare the hook were unsuccessful.The patient underwent a second attempt to remove filter via a complex percutaneous removal approximately two months later in which the hook was tilted and embedded in the caval wall.The doctor attempted to snag the hook with a catheter wire and after multiple attempts, including the use of a laser sheath, the procedure was abandoned.A post-venography revealed that over half of the filter was embedded in the caval wall and not just the retrieval hook.The patient submitted herself to a ct scan a day following the second removal attempt in which the report revealed collateral vessel in the pelvis and chronic occlusion of left common iliac vein.The patient again submitted herself to an ultrasound a month later in which the report revealed a non-occlusive thrombus in the right popliteal vein that was suspect to being chronic.The patient further states she suffered blood clots, clotting, and/or occlusion of the ivc and suffered chest pain and shortness of breath due to these complications.The following additional information received per the medical records state the patient has a history of tobacco use and protein c deficiency.During the implant procedure, a 6 french sheath was placed in the right femoral vein.Angiography demonstrated the location of the renal veins and the optease filter was deployed.During the first implant removal attempt, no snare was able to grab the hook and the sheath could not be advanced over the hook because the filter was embedded in the ivc wall.After multiple attempts, the procedure was concluded.A venogram confirmed that there was no thrombus within the filter.The filter was noted to have exceeded its recommended dwell time prior to attempted retrieval attempt.During the second implant removal attempt, the hook would not enter the sheath and only moved around behind the sheath.After two hours of attempting to remove the hook, the procedure was ended.A final venography showed the filter with no evidence of clot or filter fracture.The venography did reveal that half of the filter was either embedded within the wall of the ivc or covered with neointima.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8288929
• MDR Text Key: 134495757
• Report Number: 1016427-2019-02464
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• 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
• Report Date: 05/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2019
• Patient Sequence Number: 1
• Patient Age: 27 YR