MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

Device Problem Unintended Movement (3026)

Patient Problems Stroke/CVA (1770); Coagulation Disorder (1779); Occlusion (1984)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.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 set for the treatment of deep vein thrombosis (dvt).The device was positively identified by the patient¿s medical records.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.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 her body.The following additional information received per the patient profile form (ppf) indicates that the filter is unable to be removed.However, it is noted that a removal will not be attempted.The patient reports to be experiencing pains in the left leg.According to the information received in the medical records, the patient has a history of dvt, obstructive sleep apnea, cerebrovascular disease (transient ischemic attacks), hypertension and diabetes.Two days prior to the filter placement, the patient underwent a computerized tomography (ct) chest scan.The lungs were noted to be clear, there were no pulmonary arterial defects noted to suggest pulmonary embolisms (pe), no acute pulmonary disease, no evidence of thoracic aortic dissection, and no pericardial effusions.The indication for the filter placement was to prevent pe.During the filter placement procedure via the right femoral artery, the filter was deployed distally to the renal veins without any complications.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient reports migration of the entire filter to the heart, blood clots, clotting, and/or occlusion of the ivc.

Manufacturer Narrative

As reported, the patient had implant of a trapease permanent inferior vena cava (ivc) filter set for the treatment of deep vein thrombosis (dvt).Per the medical records, history includes dvt, obstructive sleep apnea, cerebrovascular disease (transient ischemic attacks), hypertension and diabetes.The indication was to prevent pe.During the filter placement, the filter was deployed distal to the renal veins without any complications.The patient tolerated the procedure well.Per the patient profile form (ppf), the patient reports migration of the entire filter to the heart, blood clots, clotting, and/or occlusion of the inferior vena cava (ivc).The patient further reports stroke, anxiety and pain in the left leg.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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Stroke is a known potential adverse event associated to the use of ivc filters.The filter is designed to stop intermediate to large thrombi; however, due to the open cell design is unable to capture small emboli.Further, an excessive clot burden within the filter may allow clot to pass through the device and travel to the heart, lungs and brain.Anxiety and leg pain 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.

Event Description

As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter set for the treatment of deep vein thrombosis (dvt).The device was positively identified by the patient¿s medical records.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.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 her body.The following additional information received per the patient profile form (ppf) indicates that the filter is unable to be removed.However, it is noted that a removal will not be attempted.The patient reports to be experiencing pains in the left leg.According to the information received in the medical records, the patient has a history of dvt, obstructive sleep apnea, cerebrovascular disease (transient ischemic attacks), hypertension and diabetes.Two days prior to the filter placement, the patient underwent a computerized tomography (ct) chest scan.The lungs were noted to be clear, there were no pulmonary arterial defects noted to suggest pulmonary embolisms (pe), no acute pulmonary disease, no evidence of thoracic aortic dissection, and no pericardial effusions.The indication for the filter placement was to prevent pe.During the filter placement procedure via the right femoral artery, the filter was deployed distally to the renal veins without any complications.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient reports migration of the entire filter to the heart, blood clots, clotting, and/or occlusion of the inferior vena cava (ivc).According to the amended discovery form, the patient received the ivc filter for deep vein thrombosis (dvt) and alleges a stroke as a medical condition resulting in treatment to be attributable to the implanted ivc filter.The patient further stated that the device defect, has resulted in additional follow up care, monitoring and treatment than normal and has caused and continues to cause emotional distress.

Manufacturer Narrative

Complaint conclusion: as reported, the patient underwent implantation of a trapease inferior vena cava (ivc) filter for the treatment of deep vein thrombosis (dvt).Per the medical records, the patient has a history of dvt, obstructive sleep apnea, cerebrovascular disease (transient ischemic attacks), hypertension and diabetes.Two days prior to the filter placement, the patient underwent a computerized tomography (ct) chest scan.The lungs were noted to be clear, there were no pulmonary arterial defects noted to suggest pulmonary embolisms (pe), no acute pulmonary disease, no evidence of thoracic aortic dissection, and no pericardial effusions.The indication for the filter placement was to prevent pe.During the filter placement procedure via the right femoral artery, the filter was deployed distally to the renal veins without any complications.The patient tolerated the procedure well.The device was positively identified by the patient¿s medical records.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.Per the patient profile form (ppf) the filter is unable to be removed; however, there are no documented retrieval attempts.The patient reports pains in the left leg.According to the information received in the patient profile form (ppf), the patient reports migration of the entire filter to the heart, blood clots, clotting, and/or occlusion of the ivc.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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Leg pain 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: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7653739
• MDR Text Key: 112840448
• Report Number: 1016427-2018-01611
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2019

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: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/30/2018
• Supplement Dates Manufacturer Received: 07/05/2018; 12/03/2019
• Supplement Dates FDA Received: 07/11/2018; 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6 FR LONG SIDEPORT SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 42 YR
• Patient Weight: 83