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

Catalog Number 466P306AU

Device Problem Migration (4003)

Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 11/01/2008

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused migration, perforation of the filter struts, caval thrombosis, blood clot/clotting and occlusion of the inferior vena cava (ivc) and a lifetime of anticoagulation post implant, and pain post implant.The indication for the filter implant has not been provided and there is currently no additional information available for review.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 pe via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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, clotting, caval thrombosis and/or occlusion do not indicate a device malfunction.Rather, patient, pharmacological factors vessel characteristics may have contributed to these events.Without images or procedural films for review, the reported filter migration and ivc perforation could not be confirmed and the exact cause could not be determined.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the 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 ivc 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.It is unknown if the tilt contributed to the reported perforation.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Due to the nature of the complaint the reported pain experienced by the patient could not be further clarified nor a cause determined.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to migration, perforation of the filter struts, caval thrombosis, blood clot/clotting and occlusion of the ivc, lifetime anticoagulation post implant, and pain post implant.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

After further review of additional information received.As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, history includes recurrent pulmonary emboli, deep vein thrombosis, shortness of breath on exertion, medical non-compliance, respiratory failure requiring ventilatory support and a history of drug abuse.The filter was deployed at the l-2/l-3 level.The proper position was confirmed with use of fluoroscopy.There were no complications and the patient tolerate the procedure well.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to migration, perforation of the filter struts, caval thrombosis, blood clot/clotting and occlusion of the ivc, lifetime anticoagulation post implant, and pain post implant.Per the patient profile form (ppf), the patient reports perforation of filter strut(s) outside the ivc, migration of entire filter other than to heart, blood clots, clotting, and/or occlusion of the ivc.A ct scan revealed caval thrombosis and blood clots, clotting and/or occlusion and migration of the ivc.A later ct scan revealed migration and perforation.The patient further reports emotional distress, mental anguish, anxiety and stress.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.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.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots, thrombosis and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety 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.

Manufacturer Narrative

Section b5: additional information received per the medical records indicate that the patient has a history of recurrent pulmonary emboli, deep vein thrombosis, shortness of breath with dyspnea on exertion, medical non-compliance, respiratory failure requiring ventilatory support and a history of drug abuse.  the filter was deployed via the patient's right femoral vein.It was placed at the l-2/l-3 level.The proper position was confirmed with use of fluoroscopy.There were no complications and the patient tolerate the procedure well.  additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the ivc, migration of entire filter other than to heart, blood clots, clotting, and/or occlusion of the ivc.The patient became aware of the reported events five months after the index procedure.A computed tomography (ct) scan performed of the patient¿s trapease revealed caval thrombosis and blood clots, clotting and/or occlusion and migration of the ivc.A later ct scan revealed migration and perforation.These injuries have caused emotional distress, mental anguish, anxiety and stress.Additional information is pending and will be submitted within 30 days of receipt.

• 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: 9373713
• MDR Text Key: 170208305
• Report Number: 1016427-2019-03589
• Device Sequence Number: 1
• Product Code: DTK
• 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: 02/21/2020

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: R0208660
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 01/06/2020; 01/31/2020
• Supplement Dates FDA Received: 02/05/2020; 02/21/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE WIRE; UNKNOWN INTRODUCER SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 31 YR