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

Catalog Number 466P306AU

Device Problems Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Occlusion (1984); Pain (1994); Thrombosis (2100); Perforation of Vessels (2135); Numbness (2415); Vascular System (Circulation), Impaired (2572)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots and recurrent 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 significant medical expenses, and pain and suffering, and other damages.The product was not returned for analysis.Additionally, as the sterile lot number was not available, a device history record (dhr) review could not 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.Blood clots within the filter also does 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 and lesion characteristics.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore no corrective action will be taken.Please note that device reported is an optease vena cava filter for which the catalog and lot numbers are not available.

Event Description

As reported by the legal brief, the patient underwent placement of optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots and recurrent 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 significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

According to the amended ppf, seven years and eleven months post implantation of the ivc filter the patient reports to have also suffered from perforation of filter strut(s) outside the ivc, the filter being tilted, and the filter being embedded in the wall of the ivc.However, still no reports of attempted ivc filter removal are noted.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

The patient was implanted with a trapease filter and not an opteease filter.The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the reported events seven years and eleven months post implantation.The patient reports to have clotting, occlusion of the inferior vena cava (ivc) and the filter is unable to be retrieved.However, there have been no known attempts to remove the filter.The patient also reports to be suffering from leg numbness due to the clots, have circulation problems and pain.According to the information received in the medical records, the patient has a history of anxiety, arthritis, atrial fibrillation, depression, gallbladder disease, blood clots, pulmonary embolism (pe), morbid obesity and hypertension.Seven years and eleven months post implantation the patient had acute bilateral pulmonary embolism (pe).At this time, the patient underwent thrombolysis for lower extremity dvt.The filter was placed prophylactically due to the patient¿s medical history of dvt and pe prior to gastric bypass surgery.During the implantation procedure, the filter was deployed in good position below the renal veins.As reported, the patient underwent placement of trapease inferior vena cava (ivc) filter.The filter was placed prophylactically due to the patient¿s medical history of dvt and pe prior to gastric bypass surgery.During the implantation procedure, the filter was deployed in good position below the renal veins.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots and recurrent 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 significant medical expenses, and pain and suffering, and other damages.Per the patient profile form (ppf), , the patient became aware of the reported events seven years and eleven months post implantation.The patient reports to have clotting, occlusion of the inferior vena cava (ivc) and the filter is unable to be retrieved.However, there have been no known attempts to remove the filter.The patient also reports to be suffering from leg numbness due to the clots, have circulation problems and pain.Per the medical records, the patient has a history of anxiety, arthritis, atrial fibrillation, depression, gallbladder disease, blood clots, pulmonary embolism (pe), morbid obesity and hypertension.Seven years and eleven months post implantation the patient had acute bilateral pulmonary embolism (pe).At this time, the patient underwent thrombolysis for lower extremity dvt.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.Blood clots, pe and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Pin, numbness and poor peripheral circulation do not represent device malfunctions and may be related to underlying patient conditions.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

(product problem (e.G., defects/malfunctions)).(b)(4).As reported, the patient underwent placement of trapease inferior vena cava (ivc) filter.Per in the medical records, the patient has a history of anxiety, arthritis, atrial fibrillation, depression, gallbladder disease, blood clots, pulmonary embolism (pe), morbid obesity and hypertension.The filter was placed prophylactically due to the patient¿s medical history of dvt and pe prior to gastric bypass surgery.During the implantation procedure, the filter was deployed in good position below the renal veins.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots and recurrent deep vein thrombosis (dvt).Per the patient profile form (ppf), the patient became aware of the reported events seven years and eleven months post implantation.The patient reports to have clotting, occlusion of the inferior vena cava (ivc) and the filter is unable to be retrieved.However, there have been no known attempts to remove the filter.The patient also reports to be suffering from leg numbness due to the clots, have circulation problems and pain.Seven years and eleven months post implantation the patient had acute bilateral pulmonary embolism (pe).At this time, the patient underwent thrombolysis for lower extremity dvt.According to the amended ppf, seven years and eleven months post implantation of ivc filter the patient reports to have also suffered from perforation of filter strut(s) outside the ivc, the filter being tilted, and the filter being embedded in the wall of the ivc.However, still no reports of attempted ivc filter removal are noted.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.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 also reported that there was perforation of the ivc; however, 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.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.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.Blood clots, pulmonary embolism and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Poor circulation and 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7205519
• MDR Text Key: 97747988
• Report Number: 1016427-2018-01000
• 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,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/04/2018

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 Catalogue Number: 466P306AU
• Device Lot Number: R0107450
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 03/09/2018; 03/29/2018; 05/04/2018
• Supplement Dates FDA Received: 03/29/2018; 04/27/2018; 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 57 YR