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

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problems Perforation (2001); Stenosis (2263)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is a trapease vena cava filter and for which the catalog and lot numbers are not currently available.Patient age and medical history were also not provided.If obtained, a follow up report will be submitted within 30 days upon receipt.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 the filter to tilt with the apex against the wall, there was a 6mm mesenteric perforation and ivc stenosis.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 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.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.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, 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 reported events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported perforation, tilt and stenosis could not be confirmed or further clarified.There is nothing to suggest that the reported event is 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.

Event Description

As reported in the legal brief, the patient was treated with a trapease vena cava filter but the filter subsequently malfunctioned and caused injury, damage, including, but not limited to there is specific evidence that the filter was tilted with the apex against the wall, there was a 6mm mesenteric perforation and ivc stenosis.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.

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 the filter to tilt with the apex against the wall, there was a 6mm mesenteric perforation and ivc stenosis.The patient reported becoming aware of perforation of filter struts into organs, tilt and stenosis approximately nine years and ten months post implant.The patient also reported back pain, walking difficulty, deep vein thrombosis (dvt) from filter to thighs, extreme pain and swelling of both legs, dizziness, and shortness of breath related to the filter.The patient indicated that the dvt¿s damaged their legs after removal of the clots and 8 mores stents were placed to keep the veins open.According to the medical record the patient had a history of dvt and portal vein thrombosis due to lupus anticoagulant, hypertension, left breast mass, pericardial cysts, hypokalemia, anxiety, ulcerative colitis, significant tiredness and lethargy due to anemia, obstructive sleep apnea, chest pain, shortness of breath, morbid obesity, and heavy menses due to fibroids- requiring a hysterectomy.The indication for the filter implant was dvt of the right lower leg involving the peroneal vein and past history of gastrointestinal bleeding while on anticoagulation.The patient also refuses blood transfusions.The filter was placed via the right common femoral vein and deployed just below the renal vein.Approximately nine years and ten months post implant a computed tomography (ct) scan was performed to evaluate the filter.Results of the scan noted ivc filter and a vascular graft with the proximal portion of the graft located at the level of the origin of the renal veins.The ivc filter is about 2.5cm distal to the origin of the bilateral renal veins.The prongs of the filter extend into the soft tissues.A second vascular graft starting at the level of the ivc filter and extending anteriorly in the ivc into the left common iliac vein.The first graft starts at the level of the renal veins and extends posteriorly and eventually into the proximal right common iliac vein.Incidental findings noted degenerative changes of the lumbar spine, right basilar atelectasis (seen on previous exams), moderate hiatal hernia (noted on previous exams).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.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.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, 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 reported events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported perforation, tilt and stenosis could not be confirmed or further clarified.Pain does not represent a device malfunction and may be related to patient comorbidities.There is nothing to suggest that the reported event is 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.

Event Description

According to the patient profile form: the patient reported becoming aware of perforation of filter struts into organs, filter tilt and stenosis approximately nine years and ten months post implant.The patient also reported back pain, walking difficulty, deep vein thrombosis (dvt) from filter to thighs, extreme pain and swelling of both legs, dizziness, shortness of breath related to the filter.The patient indicated that the dvt¿s damaged their legs after removal of the clots and 8 mores stents were placed to keep the veins open.According to the medical records the patient had a history of deep vein thrombosis (dvt) and portal vein thrombosis due to lupus anticoagulant, hypertension, left breast mass, pericardial cysts, hypokalemia, anxiety, ulcerative colitis, significant tiredness and lethargy due to anemia, obstructive sleep apnea, chest pain, shortness of breath, morbid obesity, heavy menses due to fibroids- requiring a hysterectomy.The indication for the filter implant was dvt of the right lower leg involving the peroneal vein and past history of gastrointestinal bleeding while on anticoagulation.The patient also refuses blood transfusions.The filter was placed via the right common femoral vein and deployed just below the renal vein.Approximately nine years and ten months post implant a computed tomography (ct) scan was performed to evaluate the filter.Results of the scan noted ivc filter and a vascular graft with the proximal portion of the graft located at the level of the origin of the renal veins.The ivc filter is about 2.5cm distal to the origin of the bilateral renal veins.The prongs of the filter extend into the soft tissues.A second vascular graft starting at the level of the ivc filter and extending anteriorly in the ivc into the left common iliac vein.The first graft starts at the level of the renal veins and extends posteriorly and eventually into the proximal right common iliac vein.Incidental findings noted degenerative changes of the lumbar spine, right basilar atelectasis (seen on previous exams), moderate hiatal hernia (noted on previous exams).

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12228246
• MDR Text Key: 263568786
• Report Number: 1016427-2021-05125
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female