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

Model Number 466P306AU

Device Problems Fracture (1260); Unintended Movement (3026)

Patient Problems Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of recurrent deep vein thrombosis (dvt), endometriosis and recurrent thrombophlebitis.The indication for the filter placement was reported to be for prophylaxis against recurrent dvt prior to undergoing planned, extensive pelvic surgery.The filter was implanted via the right femoral vein and placed in an infrarenal position.The patient subsequently underwent an abdominal hysterectomy.More than seventeen years after the filter implantation, the patient became aware that the filter had tilted and fractured with segments retained within the inferior vena cava (ivc).The patient also reported that filter struts had perforated outside the ivc.In addition, the filter had become embedded and was irretrievable.No documented attempts related to an attempted filter retrieval was provided.The patient further reported having experienced anxiety associated with the filter.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 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, fracture, ivc perforation and device embedment 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 tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that 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.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 complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.The predominant concern for embedding within the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.The trapease vena cava filter is designed for permanent implantation.Endothelialization has been shown to occur in as short a period as twelve days.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.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 by 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 fracture of the filter, perforation and tilting.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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the patient was reported to have a history of deep vein thrombosis (dvt), endometriosis and recurrent thrombophlebitis.Placement of the inferior vena cava (ivc) filter was advised due to high risk for recurrent deep vein thrombosis, as the patient was to undergo extensive pelvic surgery.The right groin was prepped and draped in the usual operative sterile fashion.An introducer needle was inserted into the femoral vein and a guidewire was passed fluoroscopically up into the superior vena cava at the l1-l2-3 region.An introducer catheter was inserted over the guidewire and positioned at the l2 region.An inferior venacavagram was then performed isolating the level of the renal veins and measuring the vena cava.The filter was inserted, positioned and deployed at the l2-l3 junction.The index procedure was followed by an abdominal hysterectomy.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc, tilting, filter embedded and unable to be retrieved with no documented attempts to remove the filter and fractured filter struts retained within the inferior vena cava, becoming aware of these events approximately seventeen years and seven months after the filter implantation.The 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 lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 12306371
• MDR Text Key: 265980613
• Report Number: 1016427-2021-05272
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2006
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0303074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Date Device Manufactured: 03/12/2003
• 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
• Treatment: UNK NEEDLE, UNK GUIDEWIRE, UNK CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR