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

Catalog Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.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 tilt of the filter with the superior end embedded within the inferior vena cava (ivc), perforation of all filter strut(s) outside the wall of the ivc with multiple struts perforating into surrounding tissue/organs.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.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.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.Vessel perforation is a known adverse event associated with implanting vena cava filters.The ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Ivc filter tilt has been associated with operator technique, the anatomy of the vessel, specifically asymmetry and tortuosity.Without images or procedural films for review, the reported filter perforation, organ perforation and tilt could not be confirmed or further clarified, and the exact cause determined.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.Please note that this is the initial report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilt of the filter with the superior end embedded within the inferior vena cava (ivc), perforation of all filter strut(s) outside the wall of the ivc with multiple struts perforating into surrounding tissue/organs.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, suffering, distress and other damages.

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 filter tilt, with the superior end embedded within the inferior vena cava (ivc), perforation of all filter strut(s) outside the wall of the ivc with multiple struts perforating into surrounding tissue/organs.The patient reported becoming aware of perforation, perforation into organs, tilting and embedment approximately nine years and ten months post implant.The patient also reports to have experienced anxiety, groin, pelvic pain, nerve and body pain post implant, in addition to spams that have caused erection complications, requiring the use of pain medication and muscle relaxers.Approximately nine years and nine months post implant, the patient underwent a computed tomography (ct) scan to evaluate the filter.The scan results noted that the filter is tilted anteriorly at the superior end and it is embedded within the ivc wall, perforating through the ivc with multiple struts extending extraluminal.One anterior and a lateral strut perforate the ivc wall 5mm and 4mm respectively and contact the bowel.Two medial struts (5mm), two posterior struts (5mm and 6mm), and a lateral strut (4mm) perforate and reside within the soft tissues.The report also notes that the original function of this ivc filter is permanent; therefore, it cannot be removed by a percutaneous approach.The indication for the filter implant, medical history and procedural details have not been provided.There is currently no additional information available for review.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 filter is intended for permanent placement.Vessel perforation is a known adverse event associated with implanting vena cava filters.The ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Ivc filter tilt has been associated with operator technique, the anatomy of the vessel, specifically asymmetry and tortuosity.Without images or procedural films for review, the reported filter perforation, organ perforation and tilt could not be confirmed or further clarified, and the exact cause determined.Due to the nature of the complaint the reported pain experienced by the patient could not be further clarified.Pain and anxiety do 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.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilt of the filter with the superior end embedded within the inferior vena cava (ivc), perforation of all filter strut(s) outside the wall of the ivc with multiple struts perforating into surrounding tissue/organs.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, suffering, distress and other damages.Approximately nine years and nine months after the filter was implanted, the patient underwent a computed tomography (ct) scan indicated for filter evaluation.The scan results revealed the superior end of the cordis permanent trapease ivc filter at the l1-2 interspace.The ivc filter is tilted anteriorly at the superior end and it is embedded within the ivc wall, perforating through the ivc with multiple struts extending extraluminal.All the struts of the ivc filter perforate the ivc up to 6mm.One anterior strut perforates the ivc wall 5mm and contacts the bowel.Two medial struts perforate the ivc wall both 5mm and reside within the soft tissues.Two posterior struts perforate the ivc wall 5mm and 6mm and reside within the soft tissues, and another lateral strut perforates the ivc wall 4mm and contacts the bowel and another lateral strut perforates the ivc wall 4mm and resides within the soft tissues.The report also note that the original function of this ivc filter is permanent; therefore, it cannot be removed by a percutaneous approach.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately nine years and ten months after the filter implantation.The patient reports ivc perforation, perforation of filter struts into organs, tilting and embedment.The patient further asserts to have suffered from groin and pelvic pain post implant, in addition to spams that have caused erection complications, and nerve and body pain requiring the use of pain medication and muscle relaxers.The patient further experienced anxiety related to the filter.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10157566
• MDR Text Key: 195270000
• Report Number: 1016427-2020-04021
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15108361
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 33 YR