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

Catalog Number 466P306AU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Stenosis (2263); Vascular System (Circulation), Impaired (2572); No Code Available (3191); Thrombosis/Thrombus (4440)

Event Date 08/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter.The device was implanted below the influx of the patient¿s renal veins.The device in the patient was positively identified by medical records.As of the present, the patient is still implanted with the device.As the result of the trapease filter¿s installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside his body.Per the patient profile form (ppf), the patient received a trapease filter.Approximately on or about six years and twenty-eight days post implantation of the inferior vena cava (ivc) filter, a scan was performed on the patient and the patient became aware of the alleged events.The patient reports mood swings, difficulty concentrating, loss of focus, depression and anxiety.Further, it was reported that the caliber of the ivc is significantly attenuated at the level of and below the level of the ivc filter.Significant venous collaterals have formed likely as a result.There has been no attempt to remove the filter.Per the medical records, a computerized tomography (ct) scan was done approximately on or about six years and twenty-eight days post implantation of the ivc filter to assess the placement of the filter.The ct scan revealed that the filter is in place below the influx of the renal veins and the caliber of the ivc is significantly attenuated at the level of and below the level of the ivc filter, significant venous collaterals have formed likely as a result.In addition, the ct scan revealed likely gallbladder stones and post-surgical changes related to roux-en-y gastric bypass.Additionally, per the medical records, the patient had exchange of tracheostomy due to tracheostomy dysfunction, and insertion of the ivc filter due to deep vein thrombosis (dvt) and blood clots performed the same day.The consents were signed by the patient¿s wife; however, the patient was able to assist transfer to operating table.The preoperative diagnosis was right lower extremity dvt and dysfunctional tracheostomy.The tracheostomy was replaced without report of difficulty.Then, they proceeded to the ivc filter implantation via the right femoral vein, finding the second and third vertebrae using fluoroscopy and a venogram to confirm placement between the renal vein and the bifurcation of the iliac veins.The patient tolerated the procedures well.The patient¿s history includes septic shock, acute renal failure, acute respiratory distress, pulmonary edema, diabetes, morbid obesity, obstructive sleep apnea, ards, persistent anemia treated with blood transfusion and status post gastric bypass with leakage leading to peritonitis.The patient also had a history of debridement and placement of a wound vacuum to a sacral ulcer.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, the patient underwent implantation of a trapease permanent inferior vena cava (ivc) filter.The device was implanted below the influx of the patient¿s renal veins.Per the medical records, the patient had exchange of tracheostomy due to tracheostomy dysfunction, and insertion of the ivc filter due to deep vein thrombosis (dvt) and blood clots, performed the same day.The consents were signed by the patient¿s wife; however, the patient was able to assist transfer to operating table.The preoperative diagnosis was right lower extremity dvt and dysfunctional tracheostomy.The tracheostomy was replaced without report of difficulty.Then, they proceeded to the ivc filter implantation via the right femoral vein, finding the second and third vertebrae using fluoroscopy and a venogram to confirm placement between the renal vein and the bifurcation of the iliac veins.The patient tolerated the procedures well.The patient¿s history includes septic shock, acute renal failure, acute respiratory distress, pulmonary edema, diabetes, morbid obesity, obstructive sleep apnea, ards, persistent anemia treated with blood transfusion and status post gastric bypass with leakage leading to peritonitis.Per the patient profile form (ppf), approximately six years post implantation of the inferior vena cava (ivc) filter, a scan was performed.Further, it was reported that the caliber of the ivc is significantly attenuated at the level of and below the level of the ivc filter.Significant venous collaterals have formed likely as a result.There has been no attempt to remove the filter.Per the medical records, a computerized tomography (ct) scan was done approximately six years post implantation.The ct scan revealed that the filter is in place below the influx of the renal veins and the caliber of the ivc is significantly attenuated at the level of and below the level of the ivc filter, significant venous collaterals have formed likely as a result.In addition, the ct scan revealed likely gallbladder stones and post-surgical changes related to roux-en-y gastric bypass.The patient reports mood swings, difficulty concentrating, loss of focus, depression and anxiety.The filter remains implanted; thus, unavailable for analysis.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 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.Collateral circulation and injury to the inferior vena cava do not represent a device malfunction and may be related to underlying patient related issues.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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.Per information received in the second amended ppf, the patient reports the filter to be embedded in wall of the ivc and the device as being unable to be retrieved.However, no known attempts to retrieve the filter have been made.As reported, the patient underwent implantation of a trapease permanent inferior vena cava (ivc) filter.The device was implanted below the influx of the patient¿s renal veins.Per the medical records, the patient had exchange of tracheostomy due to tracheostomy dysfunction, and insertion of the ivc filter due to deep vein thrombosis (dvt) and blood clots, performed the same day.The consents were signed by the patient¿s wife; however, the patient was able to assist transfer to operating table.The preoperative diagnosis was right lower extremity dvt and dysfunctional tracheostomy.The tracheostomy was replaced without report of difficulty.Then, they proceeded to the ivc filter implantation via the right femoral vein, finding the second and third vertebrae using fluoroscopy and a venogram to confirm placement between the renal vein and the bifurcation of the iliac veins.The patient tolerated the procedures well.The patient¿s history includes septic shock, acute renal failure, acute respiratory distress, pulmonary edema, diabetes, morbid obesity, obstructive sleep apnea, ards, persistent anemia treated with blood transfusion and status post gastric bypass with leakage leading to peritonitis.Per the patient profile form (ppf), approximately six years post implantation of the inferior vena cava (ivc) filter, a scan was performed.Further, it was reported that the caliber of the ivc is significantly attenuated at the level of and below the level of the ivc filter.Significant venous collaterals have formed likely as a result.There has been no attempt to remove the filter.Per the medical records, a computerized tomography (ct) scan was done approximately six years post implantation.The ct scan revealed that the filter is in place below the influx of the renal veins and the caliber of the ivc is significantly attenuated at the level of and below the level of the ivc filter, significant venous collaterals have formed likely as a result.In addition, the ct scan revealed likely gallbladder stones and post-surgical changes related to roux-en-y gastric bypass.The patient reports mood swings, difficulty concentrating, loss of focus, depression and anxiety.Per information received in the second amended ppf, the patient reports the filter to be embedded in wall of the ivc and the device as being unable to be retrieved.However, no known attempts to retrieve the filter have been made.The filter remains implanted; thus, unavailable for analysis.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 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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Collateral circulation and injury to the inferior vena cava do not represent a device malfunction and may be related to underlying patient related issues.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.

Manufacturer Narrative

As reported a patient underwent a surgical procedure to implant a trapease permanent vena cava filter.The device was implanted below the influx of the patient¿s renal veins.The patient reported becoming aware of significant attenuation at the level of and below the level of the ivc filter and resulting venous collateral circulation from a computerized tomography (ct) scan that was performed approximately six years and twenty-eight days post implant.The patient also reported mood swings, depression and anxiety related to the filter.The ct scan also likely gallbladder stones and post-surgical changes related to roux-en-y gastric bypass.According to the medical records, the patient history includes septic shock, acute renal failure, acute respiratory distress, pulmonary edema, diabetes, morbid obesity, obstructive sleep apnea, ards, persistent anemia treated with blood transfusion and status post gastric bypass with leakage leading to peritonitis.The patient also had a history of debridement and placement of a wound vacuum to a sacral ulcer.The patient underwent tracheostomy exchange and ivc filter insertion on the same day.The preoperative diagnosis was right lower extremity dvt and dysfunctional tracheostomy.The tracheostomy was replaced without report of difficulty.The filter was placed via the right femoral vein and deployed between the renal vein and the bifurcation of the iliac veins, as confirmed buy venogram.The patient tolerated the procedures well.The patient subsequently reported becoming aware of the filter being embedded and unable to be retrieved approximately six years post implant.No retrieval attempts have been made.Additional information indicated that the patient has experienced caval thrombosis.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 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 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.Following implant, the predominant concern for embedding with in the wall of the ivc is the development of endothelialization, the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Trapease ivc filters are indicated for permanent placement.Caval thrombosis was reported.Stenosis, blood clots, clotting and occlusion of the device or the vasculature do not represent a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Collateral circulation develops as a result of inherent circulation patterns being impeded.Without imaging available for review the events could not be confirmed nor a cause attributed.Anxiety does 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.

Event Description

According to the information received in an updated legal brief (short form), the patient additionally reports the filter malfunctioned and caused caval thrombosis.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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
• MDR Report Key: 7597573
• MDR Text Key: 110935975
• Report Number: 1016427-2018-01527
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15025194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDEWIREUNKNOWN INTRODUCER; UNKNOWN GUIDEWIREUNKNOWN INTRODUCER
• Patient Outcome(s): Life Threatening
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 129 KG