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

Model Number 466P306AU

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problems Coagulation Disorder (1779); Occlusion (1984)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

Additional information: (concomitant medical products: 7fr catheter, guidewire).Complaint conclusion: as reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the indication was traumatic brain injury.During the implant procedure, the trapease filter was deployed at the level of l2 without complication or migration.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture and occlusion that caused damages to the patient.Per the patient profile form (ppf), the patient reports fracture, filter embedded in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc.An unsuccessful percutaneous removal attempt was performed seven years and seven months post implant.The patient also reports anxiety.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.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.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 by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture and occlusion that caused damages to the patient.The following additional information received per the medical records state that the patient has a preoperative diagnosis of traumatic brain injury.During the implant procedure, the right common femoral vein was accessed.The trapease filter was deployed at the level of l2 without complication or migration.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient became aware of the reported seven years and seven months post implant.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture, filter embedded in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc.An unsuccessful percutaneous removal attempt was performed seven years and seven months post implant.The patient also reports anxiety.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes 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: 10203359
• MDR Text Key: 196851520
• Report Number: 1016427-2020-04087
• 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: 06/26/2020

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 Expiration Date: 11/30/2014
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15522425
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2020
• Initial Date FDA Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2011
• 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: 40 YR