MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problem Failure to Align (2522)

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

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently tilted posteriorly at the superior end and it contacts the ivc wall.The ivc filter is tilted laterally at the inferior end and it contacts the ivc wall.All the struts of the ivc filter perforate the ivc up to 4mm and reside within the surrounding soft tissue.There is an 11mm hyperdense structure located eccentrically within the ivc filter along the laterally aspect.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.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.Ivc filter tilt has been associated with the anatomy of the vessel, 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 event.It is unknown if the tilt contributed to the reported perforation.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

As reported by the legal team, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury, damage to the patient, including, but not limited to: the ivc filter is tilted posteriorly at the superior end and it contacts the ivc wall.The ivc filter is tilted laterally at the inferior end and it contacts the ivc wall.All the struts of the ivc filter perforate the ivc up to 4mm and reside within the surrounding soft tissue.There is an 11mm hyperdense structure located eccentrically within the ivc filter along the laterally aspect.As a direct and proximate result of these malfunctions.The patient suffered life-threatening extensive medical care and treatment.As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, a3, b3, b4, b6, b7, d1, d4, d11, e1, g1, g3, g4, g7, h1, h2 and h6.Section b5: the day before that index procedure, a computed tomography (ct) angiogram scan of the chest revealed pulmonary embolism (pe) in the right upper lobe, the left upper lung and small emboli were present just below the right main pulmonary artery to the lower lobe arteries and also to the right middle lobe.The vena cava filter was implanted via the right common femoral vein.It was deployed below the level of the left and right renal veins.The patient reportedly tolerated the procedure well.Approximately three years and nine months after the index procedure, the patient had a ct scan of the abdomen and pelvis performed.The axial images were provided to an outside physician for review.The results of that review noted that the filter was tilted posteriorly at the superior end and laterally at the inferior end.All struts of the filter perforate the inferior vena cava (ivc) up to 2 mm and into surrounding soft tissue.There is a 6mm hypodense material located eccentrically along the entire length of the filter laterally, compatible with acute thrombus.The physician also noted that the original function of the filter is permanent and therefore cannot be removed by a percutaneous approach.Additional information received per the patient profile form (ppf) states that the patient experienced tilting of the filter, perforation of filter strut(s) outside the ivc, blood clots, clotting, and/or occlusion of the ivc.The form also states that the device is unable to be removed, but there was no documentation provided of any retrieval attempt.The patient became aware of the reported events approximately four years and one month after the index procedure.The patient continues to experienced anxiety related to the filter.As reported, the patient had placement of the optease inferior vena cava (ivc) filter.Per the medical records, the indication for filter was acute pulmonary embolism (pe) in the right upper lobe, the left upper lung and small emboli were present just below the right main pulmonary artery to the lower lobe arteries and also to the right middle lobe.The filter was deployed below the level of the left and right renal veins.The patient reportedly tolerated the procedure well.The filter subsequently malfunctioned and caused injury, damage to the patient, including, but not limited to: the ivc filter is tilted posteriorly at the superior end and it contacts the ivc wall.The ivc filter is tilted laterally at the inferior end and it contacts the ivc wall.All the struts of the ivc filter perforate the ivc up to 4mm and reside within the surrounding soft tissue.There is an 11mm hyperdense structure located eccentrically within the ivc filter along the laterally aspect.Approximately four years post implant, a ct scan was reviewed and revealed that the filter was tilted posteriorly at the superior end and laterally at the inferior end.All struts of the filter perforate the inferior vena cava (ivc) up to 2 mm and into surrounding soft tissue.There is a 6mm hypodense material located eccentrically along the entire length of the filter laterally, compatible with acute thrombus.The physician also noted that the original function of the filter is permanent and therefore cannot be removed by a percutaneous approach.Per the patient profile form (ppf), the patient reports tilting of the filter, perforation of filter strut(s) outside the ivc, blood clots, clotting, and/or occlusion of the ivc.The patient reports anxiety.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.It was reported that there was perforation of the ivc; 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 it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety does 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 8722697
• MDR Text Key: 148785598
• Report Number: 1016427-2019-02977
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 466P306AU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 08/12/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.038 STRAIGHT GUIDEWIRE; UNKNOWN 5FR STRAIGHT CATHETER 90CM; UNKNOWN MOVEABLE CORE GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 63 YR