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

Model Number 466P306AU

Device Problems Failure to Align (2522); Migration (4003)

Patient Problems Perforation (2001); Perforation of Vessels (2135)

Event Date 09/13/2018

Event Type  Injury  

Manufacturer Narrative

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 tilting of the filter, perforation of the filter struts and migration.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.Without images or procedural films for review, the reported filter tilt, migration and ivc perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Additionally, the timing and mechanism of the events is unknown.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.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.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.

Event Description

As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, tilting of the filter, perforation of the filter struts and migration.As a direct and proximate result, 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, pain and suffering and other damages.

Manufacturer Narrative

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 tilting of the filter, perforation of the of the filter struts and migration.The patient reported becoming aware of perforation of filter strut(s) outside the ivc, migration of the entire filter other than to the heart, tilting of the ivc filter and that a computed tomography (ct) scan performed of the trapease ivc filter also reported tilting, perforation and migration, approximately eight year post implant.The patient also reported emotional distress, mental anguish, anxiety and stress.According to the medical record the indication for the pulmonary embolism and right calf deep vein thrombosis.The results from a single intraoperative fluoroscopic spot radiograph of the midportion of the abdomen completed on the day of the index procedure, identified an inferior vena cava (ivc) filter projecting to the right of the midline at the apparent l2-3 level.No other details were provided.There is currently no additional information available for review.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 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.Without images or procedural films for review, the reported filter tilt, migration and ivc perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Additionally, the timing and mechanism of the events is unknown.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.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.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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.

Event Description

As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, tilting of the filter, perforation of the filter struts and migration.As a direct and proximate result, 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, pain and suffering and other damages.As per the perioperative record provided, the patient had a diagnosis of pulmonary embolism (pe) and right calf deep vein thrombosis (dvt).The results from a single intraoperative fluoroscopic spot radiograph of the midportion of the abdomen completed on the day of the index procedure, identified an inferior vena cava (ivc) filter projecting to the right of the midline at the apparent l2-3 level.No other details were provided.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately eight years and ten days post implantation.The patient reports perforation of filter strut(s) outside the ivc, migration of the entire filter other than to the heart, tilting of the ivc filter and that a computed tomography (ct) scan performed of the trapease ivc filter also reported tilting, perforation and migration.These injuries have caused emotional distress, mental anguish, anxiety and stress.

• 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: 9412197
• MDR Text Key: 185789770
• Report Number: 1016427-2019-03630
• 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: other
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15113859
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR