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

Catalog Number 466P306AU

Device Problems Difficult to Remove (1528); Unintended Movement (3026)

Patient Problem Pulmonary Embolism (1498)

Event Date 11/29/2005

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient: including, but not limited to, migration of the ivc filter, and pulmonary emboli.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 there were two unsuccessful attempts to remove the filter.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.No additional information is available.The product was not returned for analysis.Additionally, as the sterile lot number was not available, a 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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.There are possible patient and pharmacological factors that may have contributed to the reported event.Without images or procedural films for review, the reported filter tilt/migration could not be confirmed and the exact cause could not be determined.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.The brief noted that the filter was embedded in the wall of the ivc.Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.Without procedural films for review, the reported retrieval difficulty, unable to retrieve from the vessel wall, could not be confirmed.However, the cordis trapease® permanent vena cava filter is designed as a permanent vena cava filter.Six straight struts that contain a proximal and distal hooks are designed for fixation of the trapease filter to the vessel wall.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The off label use of this filter likely contributed to the retrieval difficulty experienced by the customer.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.Please note that this is the initial/final report for this product.

Event Description

As reported through the legal department via a legal brief indicated that the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient: including, but not limited to, migration of the ivc filter, and pulmonary emboli.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 there were two unsuccessful attempts to remove the filter.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.No additional information is available.

Manufacturer Narrative

The following additional information received per the patient profile form (ppf) indicates that the first attempt to remove the filter occurred sixteen days post implantation and the second attempt occurred three months and two days after that.The patient also reports to be suffering from fear.The patient became aware of the reported events ten years and five months post implantation.According to the information received in the medical records, the patient has a history of gastrointestinal (gi) bleeding, pe and left leg deep vein thrombosis (dvt).There were no reported complications during the filter placement procedure via the right groin.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, a patient underwent placement of a trapease inferior vena cava (ivc) filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to migration of the inferior vena cava (ivc) filter and pulmonary emboli (pe).The patient is also reported to be experiencing fear.Additionally, the device is also unable to be retrieved, there were two unsuccessful percutaneous attempts to retrieve the filter performed sixteen days and approximately three months post implant.Medical records for those procedures have not been provided.The patient became aware of the reported events ten years and five months post implantation.The indication for the filter implant was pulmonary embolism (pe) with a gastro-intestinal (gi) bleed.The patient had a fractured left fibula-tibial from one- month prior was in a cast and developed a left leg deep vein thrombosis (dvt).The patient had a repair of a gi bleed and was transferred emergently to the cardiac catheterization lab for implant of the ivc filter.There were no reported complications during the filter placement procedure via the right groin.The dictation noted of the filter implant procedure have not been provided.There is currently no additional information available for review.The product was not returned for analysis.A review of the device history record (dhr) associated with lot r0905143 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.A 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.Following implant, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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.Pulmonary embolism is a known long-term complication associated with filter implant and is listed as such in the instructions for use (ifu).Recurrent pe does not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films or post implant images available for review the reported, migration and retrieval difficulty could not be confirmed or further clarified, nor could a cause be determined.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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 ; EI
• MDR Report Key: 6901419
• MDR Text Key: 87658721
• Report Number: 1016427-2017-00632
• 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: 06/04/2018

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 Expiration Date: 08/31/2008
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0905143
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/01/2017
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 04/20/2018; 05/23/2018
• Supplement Dates FDA Received: 05/18/2018; 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MEDI-TECH COBRA 2 GLIDE CATHETER 65CM / 5F; UNKNOWN MERIT INTRODUCER SET 10CM/5F
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR