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

Model Number 466P306X

Device Problems Occlusion Within Device (1423); Defective Component (2292)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Calcium Deposits/Calcification (1758); Edema (1820); Occlusion (1984); Vascular System (Circulation), Impaired (2572)

Event Date 08/18/2015

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is antrapease vena cava filter and for which the catalog and lot numbers are not currently available.  if obtained, a follow up report will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the plaintiff at all times relevant to this action was and is a citizen and resident of the state of (b)(6).The plaintiff underwent placement of defendant's trapease vena cava filter on or about (b)(6) 2003.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, occlusion of the inferior vena cava (ivc).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 product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not 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.Thrombosis does not represent a device malfunction.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.

Manufacturer Narrative

After further review of additional information received the following have been updated accordingly.The following additional information received per the patient profile from (ppf) indicates that twelve years and six months post implantation, the patient had blood clots, clotting and that the filter was occluded.According to the medical records, the indication for the procedure was trauma with pulmonary embolism.The device was successfully deployed below the renal vein.The patient tolerated the procedure well and there were no immediate complications that occurred.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the indication for the procedure was trauma with pulmonary embolism.The device was successfully deployed below the renal vein.The patient tolerated the procedure well and there were no immediate complications that occurred.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, occlusion of the inferior vena cava (ivc).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 twelve years and six months post implantation, the patient had blood clots, clotting and that the filter was occluded.The product was not returned for analysis as it remains implanted.A review of the device history record (dhr) associated with lot r0502836 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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.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.The device¿s expiration date was april 2005.

Manufacturer Narrative

The occluded filter is reported to be causing recurrent bilateral lower extremity edema.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

The device is unable to be retrieved however, there have been no attempts made to remove the filter.The patient also reports to have problems walking and to be suffering from anxiety and stress.According to the medical records, thirteen years and eight months post implantation, the patient underwent a computerized tomography (ct) scan which showed the filter was likely chronically thrombosed.It was noted that there are curvilinear calcifications extending from the ivc into the common iliac veins related to the chronic thrombus.There are also multiple collateral vessels in the abdominal wall and the retro-peritoneum.Thirteen years and nine months post implantation the patient presented to the hospital with shortness of breath and upper abdominal pain.As reported, the patient underwent placement of a trapease permanent inferior vena cava (ivc) filter.The indication for the index procedure was trauma with pulmonary embolism.The device was successfully deployed below the renal vein.The patient tolerated the procedure well and there were no immediate complications that occurred.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, occlusion of the inferior vena cava (ivc).Per the patient profile from (ppf), twelve years and six months post implantation, the patient had blood clots, clotting and that the filter was occluded and had perforated the ivc.The occluded filter is reported to be causing recurrent bilateral lower extremity edema.The device is unable to be retrieved however, there have been no attempts made to remove the filter.Per the medical records, thirteen years and eight months post implantation, the patient underwent a computerized tomography (ct) scan which showed the filter was likely chronically thrombosed.It was noted that there are curvilinear calcifications extending from the ivc into the common iliac veins related to the chronic thrombus.There are also multiple collateral vessels in the abdominal wall and the retro-peritoneum.Thirteen years and nine months post implantation the patient presented to the hospital with shortness of breath and upper abdominal pain.The patient also reports to have problems walking and to be suffering from anxiety and stress.The product was not returned for analysis as it remains implanted.A review of the device history record (dhr) revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Collateral circulation, vascular calcification, edema in the extremities and difficulty walking do not represent device malfunctions and may be related to underlying patient coagulopathy related issues.Abdominal pain and shortness of breath do 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.

• 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: 6355508
• MDR Text Key: 68211891
• Report Number: 1016427-2017-00189
• 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,Followup
• Report Date: 04/20/2018

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 Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0502836
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/24/2017
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided; 11/28/2017; 03/19/2018; 04/10/2018
• Supplement Dates FDA Received: 02/24/2017; 12/26/2017; 04/16/2018; 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 49 YR