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

Catalog Number 466P306X

Device Problems Fracture (1260); Material Twisted/Bent (2981); Unintended Movement (3026)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolus (1830); Occlusion (1984); Perforation of Vessels (2135); Stenosis (2263)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation.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.Please note that this is the initial report for this product.Additional information is pending and will be submitted within 30 days of receipt.

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 filter tilt, filter strut perforation, stenosis and mild filter strut bending.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, and pain and suffering, and other damages.Information received per the patient profile form (ppf) states that the patient experienced filter fracture, perforation of filter struts outside the inferior vena cava (ivc), filter tilt, filter embedded in wall of the ivc, blood clots, clotting and or occlusion of the ivc.The patient became aware of the reported events fifteen years after the index procedure.Additionally the patient has experienced physiological issues, worry, anxiety and depression for which she is being treated with medication.The patient continues to experience nausea, intermittent abdominal pain, chest pain and discomfort.The patient noted that she takes two medications for her constant severe nausea.The results of computed tomography (ct) scans done approximately fifteen years after the index procedure indicate that the spleen is enlarged, cholecystectomy, previous gastric bypass noted, some fatty infiltration of the pancreas without focal lesion, the filter is tilted and there is filter perforation.The superior filter tip is tilted to the left by about 7 degrees and anteriorly by 21 degrees.The inferior tip of the filter contacts the ivc wall posteriorly and the superior tip of the filter is also contacting the ivc wall anteriorly.The scan also revealed there is filter strut perforation at the 6:00 and 12:00 positions.The filter strut at the 12:00 position does appear to show some slight bending, but no strut fracture.There is some mild ivc stenosis along the superior edge of the filter.

Event Description

Additional information received per the medical records indicate that the patient has a history of cerebrovascular accident (cva), anxiety, depression, migraines, morbid obesity and cesarean section.The indication for filter placement was the patient's history of deep vein thrombosis (dvt) and before a planned bariatric surgery.The filter was placed via the right common femoral vein.It was placed into the infrarenal area of the inferior vena cava.There were no complications.This procedure was followed by gastric by-pass with cholecystectomy.One year and four months after the index procedure, the patient presented to the emergency room (er) with a two-day history of diarrhea and 4-6 episodes of nausea and vomiting.The patient was discharged home with a diagnosis of gastroenteritis.Six years and eight months after the index procedure, the patient presented to the emergency room (er) with after being punched in the face.The patient was examined and discharged the same day.Eleven years and eight months after the index procedure, the patient presented to the emergency room (er) with multiple dog bites.The patient was examined and discharged the same day.Approximately thirteen years and seven months after the index procedure, the patient presented to the emergency room (er) with complaints of left calf pain and swelling.The patient reported that for the past three days driving six hours non-stop.The patient was noted to have an elevated d-dimer and positive for dvt at the trifurcation in the left lower extremity.The patient was placed on xarelto and discharged.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, b5, b7, g4, g7, h1, h2 and h6.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, filter strut perforation, stenosis and mild filter strut bending.The patient reported becoming aware of filter fracture, perforation, tilt, embedded, blood clots, clotting and/or occlusion of the inferior vena cava (ivc) approximately fifteen years post implant.The patient also reported physiological issues, worry, anxiety and depression, for which medication is prescribed, related to the filter.The patient experienced nausea, intermittent abdominal pain, chest pain and discomfort and takes medication for the nausea.According to the medical records provided the patient has a history of cerebrovascular accident (cva), anxiety, depression, migraines, morbid obesity, and a cesarean section.The indication for filter placement was the patient's history of deep vein thrombosis (dvt) and before a planned bariatric surgery.The filter was placed via the right common femoral vein and deployed in the infrarenal area of the ivc.There were no complications.This procedure was followed by gastric by-pass with cholecystectomy.Approximately thirteen years and seven months post implant, the patient presented to the emergency room (er) with complaints of left calf pain and swelling.The patient recounted driving six hours non-stop, for the past three days.The patient was noted to have an elevated d-dimer and positive for dvt at the trifurcation in the left lower extremity.The patient was placed on xarelto and discharged.The results of computed tomography (ct) scans done approximately fourteen years and seven months post implant indicated that the filter is tilted and there is filter perforation.The superior filter tip is tilted to the left by about 7 degrees and anteriorly by 21 degrees.The inferior tip of the filter contacts the ivc wall posteriorly and the superior tip of the filter is also contacting the ivc wall anteriorly.The scan also revealed there is filter strut perforation at the 6:00 and 12:00 positions.The filter strut at the 12:00 position does appear to show some slight bending, but no strut fracture.There is some mild ivc stenosis along the superior edge of the filter.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 ivc 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.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.Blood clots and occlusive thrombosis within the filter and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Stenosis is an abnormal narrowing of a vessel; this does not represent a device malfunction and may be related to vessel characteristics and/or patient factors.The instructions for use (ifu) states 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 tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.Mild strut bending was reported, without procedural films or post implant imaging available for review, the reported events could not be confirmed or further clarified.Pain, nausea, anxiety and depression do not represent a device malfunction and may be related to underlying patient specific issues, particularly the patient¿s history and prior bariatric surgery.There is nothing to suggest that the reported events are related to the design and/or 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 60 avenue; miami lakes FL 33014
• MDR Report Key: 10347607
• MDR Text Key: 201438783
• Report Number: 1016427-2020-04234
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 42 YR