MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

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

Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100); Vasodilatation (2127)

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to blood clots and deep vein thrombosis (dvt).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 medical expenses, and pain and suffering and other damages.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 inferior 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 development of blood clots do not represent a device malfunction.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation 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 defendants¿ trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to blood clots and deep vein thrombosis (dvt).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 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.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of bilateral pulmonary embolism, right deep vein thrombosis, hypertension, colitis, shortness of breath, bundle branch block, varicose veins, gastrointestinal bleeding, and incomplete great saphenous vein ablation.The filter was implanted via the right common femoral vein.There was some dilatation of the inferior vena cava (ivc), but this was still smaller than 3 cm.The renal veins were positioned and identified under additional venography and then the filter was deployed below the renal veins.During the placement procedure, possible iliofemoral dvt was noted.Post procedural venography revealed no evidence of compromise of the ivc or any complications.Anticoagulation therapy was started after ivc filter placement.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to blood clots and deep vein thrombosis (dvt).Per the patient profile form (ppf), one year and five months after the index procedure, the patient became aware of issues.The form states that the patient experienced occlusion of the ivc, chronic dvt of the left leg, prominent veins in the stomach, abdomen and groin as well as mental anguish.The form also states that chronic warfarin therapy makes the patient's hemorrhoids bleed easily.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 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Hemorrhoids and distended veins 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 by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to blood clots and deep vein thrombosis (dvt).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 medical expenses, and pain and suffering and other damages.Additional information received per the medical records indicate that the patient has a history of bilateral pulmonary embolism, right deep vein thrombosis, hypertension, colitis, shortness of breath, bundle branch block, varicose veins, gastrointestinal bleeding, and incomplete great saphenous vein ablation.The filter was implanted via the right common femoral vein.There was some dilatation of the inferior vena cava (ivc), but this was still smaller than 3 cm.The renal veins were positioned and identified under additional venography and then the filter was deployed below the renal veins.During the placement procedure, possible iliofemoral dvt was noted.Post procedural venography revealed no evidence of compromise of the ivc or any complications.Anticoagulation therapy was started after ivc filter placement.Per the patient profile form (ppf), one year and five months after the index procedure, the patient became aware of issues.The form states that the patient experienced occlusion of the ivc, chronic dvt of the left leg, prominent veins in the stomach, abdomen and groin as well as mental anguish.The form also states that chronic warfarin therapy makes the patient's hemorrhoids bleed easily.Additional information is pending and will be submitted within 30 days of receipt.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7373472
• MDR Text Key: 103566145
• Report Number: 1016427-2018-01281
• Device Sequence Number: 1
• Product Code: DQO
• 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,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN J-WIRE; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 69 YR