MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

Device Problems Fracture (1260); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Occlusion (1984); Perforation (2001)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.

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, tilt, and fracture, and embedment.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt, and fracture, and embedment.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 inferior vena cava (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 and embedded device 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 and fracture are unknown.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 was further reported that the filter was embedded.Endothelialization, remodeling and/or restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as twelve days.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.

Manufacturer Narrative

Complaint conclusion being updated with new information received: addition of ln; addition of ivc perforation, perforation, clotting, ivc occlusion, perforation, faintness, pain, swelling as reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.Approximately nine years and two months post-implantation, the patient became aware that the filter had severely tilted, fractured and was embedded in the wall of the inferior vena cava (ivc) and in the abdominal cavity.In addition, filter strut(s) had perforated outside the inferior vena cava (ivc) and into organs.The patient had experienced blood clots, clotting and/or occlusion of the ivc.The reported information indicated that the device was unable to be retrieved; though attempts to retrieve the device were not documented.The patient further reported that their abdominal veins were occluded by clots and scar tissue, had experienced faintness when changing positions; as well as having experienced pain and swelling of the lower extremities.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 inferior vena cava (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 device embedment, fracture, filter tilt and perforations could not be confirmed and the exact causes could not be determined.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.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.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 patient is reported to have experienced perforations; though this could not be confirmed without procedural films for review.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (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.Blood clots and thrombosis/occlusion within device or within the ivc/vasculature do not represent a device malfunction.Pain and swelling of the legs and faintness do not represent a device malfunction.Due to the nature of these complaints, the reported events could not be confirmed and the exact cause could not be determined.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.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.

Manufacturer Narrative

According to the information received in the patient profile from (ppf), the patient became aware of the events approximately nine years and two months post implantation.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture of filter struts in the abdominal cavity, perforation of filter strut(s) outside the ivc and into organs, tilt, filter embedded in wall of the ivc and other than in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc, and device unable to be retrieved.No retrieval attempt has been documented.The patient reports that the veins in the abdomen are occluded by clots and scar tissue and experiences faintness upon changing positions.The patient also experiences pain and swelling of the lower extremities.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary
• MDR Report Key: 8262326
• MDR Text Key: 133712880
• Report Number: 1016427-2019-02432
• Device Sequence Number: 1
• Product Code: DQO
• 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,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/02/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1