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

Model Number 466FXXXX

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombosis (2100)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the plaintiff is a citizen and resident of the state of (b)(6).The plaintiff underwent placement of defendants' optease vena cava filter on or about (b)(6) 2010.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc) filter, and recurrent deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the plaintiff 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, device history record (dhr) review could not be performed.The optease 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.Neither blood clots, clotting, nor thrombus within the vessel (or in the filter) represent a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.The product¿s instructions for use (ifu) indicate that filter obstruction, blood clots and thrombus formation are potential complications of filter implantation.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 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 plaintiff is a citizen and resident of the state of (b)(6).The plaintiff underwent placement of defendants' optease vena cava filter on or about (b)(6) 2010.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc) filter, and recurrent deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

The following additional information received per the patient profile from (ppf) indicates that the filter was embedded in the wall if the inferior vena cava and that it was unable to be retrieved.However, there have been no known attempts on records to remove the filter.The patient also reports to be suffering from anxiety.According to medical records, the patient¿s preoperative diagnosis was dvt on the left and was contraindicated to anticoagulation.The trapease filter was successfully deployed below the renal veins during the index procedure and the patient tolerated the procedure well.A review of the manufacturing documentation associated with this lot 15173380 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, the patient underwent placement of trapease inferior vena cava (ivc) filter.Per medical records, the patient¿s preoperative diagnosis was deep vein thrombosis (dvt) on the left and contraindicated for anticoagulation.The filter was successfully deployed below the renal veins during the index procedure and the patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc) filter, 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 following additional information received per the patient profile from (ppf) indicates that the filter was embedded in the wall if the inferior vena cava and that it was unable to be retrieved.However, there have been no known attempts on records to remove the filter.The patient also reports to be suffering from anxiety.The product was not returned for analysis as it remains implanted 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 do not represent a device malfunction.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.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.

Manufacturer Narrative

As reported, the patient underwent placement of trapease inferior vena cava (ivc) filter.Per medical records, the patient¿s preoperative diagnosis was dvt on the left and contraindicated for anticoagulation.The filter was successfully deployed below the renal veins during the index procedure and the patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc) filter, 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 following additional information received per the patient profile from (ppf) indicates that the filter was embedded in the wall if the inferior vena cava and that it was unable to be retrieved.However, there have been no known attempts on records to remove the filter.The patient also reports to be suffering from 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.Blood clots and occlusive thrombosis within the filter do not represent a device malfunction.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.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: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• MDR Report Key: 6515505
• MDR Text Key: 73493587
• Report Number: 1016427-2017-00286
• 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,Followup
• Report Date: 04/27/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15173380
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/29/2017
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/24/2017
• Supplement Dates Manufacturer Received: 12/05/2017; 01/04/2018; 03/29/2018
• Supplement Dates FDA Received: 01/02/2018; 01/22/2018; 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR