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

Model Number 466P306AU

Device Problem Break (1069)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Perforation of Vessels (2135)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

As reported, a patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the implant records, indication was recurrent deep venous thrombophlebitis of the lower extremities with pulmonary embolus.A venacavagram was performed demonstrating that the cava was patent, then the filter was deployed at level that was parallel to the cava.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to malfunction, including occlusion and perforation abutting an organ that caused injury and damage to the patient.Per the patient profile form (ppf), the patient reported ivc perforation, blood clots, clotting, and/or occlusion of the ivc, perforation abutting an organ and anxiety.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 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.It was reported that there was perforation of the ivc and organs; 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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.

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 malfunction, including occlusion and perforation abutting an organ that caused injury and damage to the patient.Per the implant records, the patient was reported to have a pre procedure diagnosis of recurrent deep venous thrombophlebitis of the lower extremities with pulmonary embolus.The femoral vein on the right groin was accessed.Under fluoroscopy guidance, a cavagram was performed at the l2-l3 level, demonstrating that the cava was opened in this area.A trapease filter was then inserted and extruded at level that was parallel to the cava.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately four years and two months after the filter implantation.The patient reported ivc perforation, blood clots, clotting, and/or occlusion of the ivc, perforation abutting an organ and patient further experienced anxiety related to the filter.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10194311
• MDR Text Key: 196469577
• Report Number: 1016427-2020-04078
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15939353
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2020
• Date Device Manufactured: 08/19/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR