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

Catalog Number 466P306X

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

Patient Problems Coagulation Disorder (1779); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Injury (2348)

Event Date 12/18/2020

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 of the filter.The indication for the filter implant has not been provided and there is currently 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 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.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.Without imaging available for review the event could not be confirmed nor a cause attributed.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 of the filter.As a direct and proximate result of these malfunctions, 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.

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 of the filter.As a direct and proximate result of these malfunctions, 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 patient developed right lower extremity deep vein thrombosis (dvt) and was status post hysterectomy with persistent vaginal bleeding while on anticoagulation.The right internal jugular vein was sterilely prepped, draped and infiltrated with lidocaine.Under ultrasound guidance, the vein was accessed using a micro puncture needle.After using a transitional dilator, a wire was then advanced into the inferior vena cava (ivc).Over the wire, a trapease filter delivery sheath was advanced into the left common iliac vein and a digital subtraction venogram was then obtained.The trapease filter was deployed in the infrarenal location.Ultrasound revealed a patent right internal jugular vein.The ivc cavogram did not reveal any abnormalities; however, post filter deployment, the completion venogram revealed some adherent thrombus at the level of the ivc filter, along the right side of the ivc.This was not visualized on the initial ivc cavogram and may have been somewhat free-floating and then trapped against the wall of the ivc by the filter.No thrombus was seen above the level of the filter.Some adherent thrombus was noted to the wall of the ivc at the level of the filter, probably residual from a cook gunther tulip retrievable filter that had been removed a few days prior to the index procedure.Approximately fourteen years and eight months after the filter was implanted, the patient underwent an abdominal computerized tomography (ct) scan indicated for filter evaluation.The scan reported the superior end of the cordis trapease permanent ivc filter at the mid l3 vertebral body.The ivc filter is tilted laterally at the superior end and it contacts the ivc wall; it is also tilted medially at the inferior end and it contacts the ivc wall, perforating through the ivc with multiple struts extending extraluminal.All the struts of the ivc filter perforate the ivc up to 11mm.An anterior strut perforates the ivc wall 5mm and contacts the bowel; one medial strut perforates the ivc wall 4mm and contacts a lymph node, and another medial strut perforates the ivc wall 11mm and resides within the soft tissues.A posterior strut perforates the ivc wall 7mm and contacts an l4 vertebral body osteophyte.One lateral strut perforates the ivc wall 9mm and contacts the right psoas muscle; another lateral strut perforates the ivc wall 5mm and resides within the soft tissues.There are two medial fractured struts which compromise the structure of the filter and cause partial collapse.The report also noted that the original function of this ivc filter is permanent; therefore, it cannot be removed by a percutaneous approach.Additionally, the scan noted that as per the medical records, fifteen days prior to the trapease filter implantation, there was deployment of a cook gunther tulip retrievable ivc filter, which was successfully retrieved in its entirety five days prior to implanting the trapease filter.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc, perforation of struts into organs, tilting in addition to two medial fractured struts retained in the body, becoming aware of these events approximately sixteen years and six months after the filter implantation.The patient further asserts to have suffered from clots post implant requiring hospitalization, mental anguish and anxiety.

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 of the filter.The patient reported becoming aware of perforation of filter struts outside the inferior vena cava (ivc), perforation of struts into organs, tilting and two medial fractured struts retained in the body, approximately sixteen years and six months post implant.The patient also reports blood clots post implant and anxiety.According to the implant record the indication for the filter implant was deep vein thrombosis (dvt) status post hysterectomy and persistent vaginal bleeding while on anticoagulation.The filter was placed via the right internal jugular vein and deployed in the infrarenal ivc.A completion venogram revealed some adherent thrombus at the level of the ivc filter, along the right side.This was not visualized on the initial ivc cavogram and may have been somewhat free-floating and then trapped against the wall of the ivc by the filter.No thrombus was seen above the level of the filter.Some adherent thrombus was noted to the wall of the ivc at the level of the filter, probably residual from a cook gunther tulip retrievable filter that had been removed a few days prior to the index procedure.Approximately fourteen years and eight months post implant, the patient underwent an abdominal computerized tomography (ct) scan indicated for filter evaluation.The results reported the superior end of the ivc filter at the mid l3 vertebral body and tilted laterally at the superior end and medially at the inferior end where it contacts the ivc wall, perforating through the ivc with multiple struts extending extraluminal up to 11mm.An anterior strut perforates 5mm and contacts the bowel; one medial strut perforates 4mm and contacts a lymph node, another medial strut perforates 11mm and resides within the soft tissues.A posterior strut perforates 7mm and contacts an l4 vertebral body osteophyte.One lateral strut perforates 9mm and contacts the right psoas muscle; another lateral strut perforates 5mm and resides within the soft tissues.There are two medial fractured struts causing partial collapse.The scan report noted that fifteen days prior to the trapease filter implant, a cook gunther tulip retrievable ivc filter was implanted, and was successfully retrieved in its entirety five days prior to implanting the trapease filter.There is currently 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 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.Blood clots, clotting, and/or device occlusion related to clotting do not indicate a device malfunction.Rather, patient, vessel characteristics and pharmacological factors may have contributed to these events.Ivc filter tilt has been associated with practitioner technique and vessel anatomy, specifically asymmetry and tortuosity.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.Anxiety does not represent a device malfunction and may be related to underlying patient specific 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.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• MDR Report Key: 11261611
• MDR Text Key: 229798105
• Report Number: 1016427-2021-04744
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK BENTSON WIRE; UNK NEEDLE, UNK DILATOR
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR