MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problem Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135)

Event Date 04/26/2017

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, perforation of all filter struts outside the inferior vena cava (ivc) and filter embedment.The indication for the filter placement, procedural details and medical history have not been provided and there is 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 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 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.Following implant, the predominant concern for embedding with in the wall of the ivc is the development of endothelialization, 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.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.The trapease ivc filters are intended for permanent placement.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Without procedural films or images for review the reported event(s) could not be confirmed or further clarified.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, tilting, perforation of all filter struts outside the inferior vena cava (ivc) and filter embedment.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

As reported, a patient had placement of a trapease inferior vena cava (ivc) filter.Per the implant records, the indication was recurrent pe, dvt and gi bleed while on anticoagulation.The filter was placed using fluoroscopy, no contrast was used, u/s was used for location, the renal veins were identified, and the filter was deployed without difficulty.The patient tolerated the procedure well, and there were no complications.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, tilting, perforation of all filter struts outside the ivc and filter embedment.Per the patient profile form (ppf), the patient reports ivc perforation, tilting, embedment of the filter, and that a computed tomography (ct) scan of the trapease filter also reported, tilting, perforation of filter struts outside the ivc and embedment and anxiety and stress.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 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.Following implant, the predominant concern for embedding with in the wall of the ivc is the development of endothelialization, 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.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.The trapease ivc filters are intended for permanent placement.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Without procedural films or images for review the reported event(s) could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.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, tilting, perforation of all filter struts outside the inferior vena cava (ivc) and filter embedment.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.Per the implant records, the filter was indicated for severe vascular disease, recurrent pulmonary emboli (pe) with bilateral femoral deep vein thrombosis (dvt) and recurrent gastrointestinal (gi) bleeding while on anticoagulation.The patient was also reported to have severe contrast allergy; and for that reason, the filter was placed using fluoroscopy and no contrast was used.The right common femoral vein was localized and accessed with a needle.A wire was advanced centrally without difficulty.Ultrasound interrogation of the femoral and iliac veins showed that there was no clot at this level.A short sheath was placed and then an intravascular ultrasound catheter was used and the external iliac, common iliac veins, and ivc were traversed.The level of the renal veins was identified and recorded and then using the catheter to mark the length as well as fluoroscopy, a trapease filter was deployed without difficulty.The patient tolerated the procedure well, and there were no complications.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately twelve years and three months after the filter implantation.The patient reports ivc perforation, tilting, embedment of the filter, and that a computed tomography (ct) scan of the trapease filter also reported, tilting, perforation of filter struts outside the ivc and embedment.These injuries have caused emotional distress, mental anguish, anxiety and stress.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 10153736
• MDR Text Key: 195269422
• Report Number: 1016427-2020-04017
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2007
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0704322
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 18G WALL NEEDLE; UNK 8F SHEATH; UNK IVUS CATHETER; UNK WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 70 YR