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

Catalog Number 466P306X

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2007

Event Type  Injury  

Manufacturer Narrative

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 perforation of struts into duodenum and psoas muscle, embedment and occlusion and inferior vena cava (ivc) ligation.The indication for the filter placement, procedural details, cause of death and medical history have not been provided.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.Occlusion was reported, however with the limited information provided the event could not be further clarified.Blood clots, clotting, and/or occlusion of the device or vasculature does not indicate a device malfunction.With the limited information provided a clinical conclusion could not be made, however, patient, vessel characteristics and pharmacological factors may have contributed to these events.The instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or post implant 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.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 perforation of struts into duodenum and psoas muscle; embedment; occlusion and inferior vena cava (ivc) ligation.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.

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 perforation of struts into duodenum and psoas muscle, embedment and occlusion and inferior vena cava (ivc) ligation.The patient reported becoming aware of perforation of filter struts into organs, migration of the entire filter other than to the heart, filter embedded, blood clots, clotting and/or occlusion of the ivc, and loss of blood requiring a blood transfusion, approximately nineteen years and four months post implant.The filter was reportedly removed via an open abdominal procedure approximately nineteen years and five months after the index procedure the patient also reported anxiety and severe pain related to the migration of the filter.According to the medical records, the patient had a history of chronic obstructive pulmonary disease (copd), chronic varicose veins and ulcerations as a result of open-heart surgery, open heart surgery as an infant with resection of a right lower extremity (rle) vein and saphenous vein, asthma, gastroesophageal reflux disease, obstructive sleep apnea, atopic dermatitis of the right lower extremity, hyperlipidemia, factor v leiden mutation, arthritis, heart murmur, cardiomegaly, chronic kidney disease, and allergic rhinitis.The indication for the filter placement was recurrent deep vein thrombosis (dvt) of the rle involving the common femoral, proximal half of the superficial femoral veins and partial occlusive disease of the popliteal vein.The filter was placed via the right internal jugular vein and deployed in the infrarenal area of the ivc.A follow up injection showed central location.There were no complications.Approximately thirteen years and three months after the index procedure the patient was seen in referral for chronic dvt of the rle and requested a venogram to evaluate the right leg pain.Approximately eighteen years and two weeks after the index procedure the patient was seen in consultation for rle dvt maintenance.A referral for vena caval filter removal was made at that time.Approximately nineteen years and four months after the index procedure the patient had a consultation for filter removal.The consult noted that the patient had intractable abdominal symptoms.Review of a computed tomography scan noted the vena cava filter appeared to be protruding from the inferior vena caval wall.After discussion with the patient, it was recommended that the filter be surgically removed.The filter was removed one month later.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.Occlusion was reported, however with the limited information provided the event could not be further clarified.Blood clots, clotting, and/or occlusion of the device or vasculature does not indicate a device malfunction.With the limited information provided a clinical conclusion could not be made, however, patient, vessel characteristics and pharmacological factors may have contributed to these events.The instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Without procedural films or post implant images for review the reported event(s) could not be confirmed or further clarified.Anxiety and pain do not represent a device malfunction and may be related to patient specific underlying 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

Additional information received per the medical records indicate that the patient has a history of chronic obstructive pulmonary disease (copd), chronic varicose veins and ulcerations as a result of open-heart surgery, open heart surgery as an infant with resection of a rle vein and saphenous vein, asthma, gastroesophageal reflux disease, obstructive sleep apnea, atopic dermatitis of the right lower extremity, hyperlipidemia, factor v leiden mutation, arthritis, heart murmur, cardiomegaly, chronic kidney disease, and allergic rhinitis.The implant record states that the indication for the filter placement was recurrent deep vein thrombosis of the right lower extremity (rle) involving the common femoral, proximal half of the superficial femoral veins and partial occlusive disease of the popliteal vein.The filter was placed via the right internal jugular vein and deployed in the infrarenal area of the inferior vena cava (ivc).A follow up injection showed central location.There were no complications.Approximately five years and two months after the index procedure the patient presented after having a syncopal episode in the shower.The patient was evaluated and the cause for the syncopal episode was not ascertained, and the patient was discharged home five days later.Three weeks later the patient underwent a cardiac catheterization for a syncope and an abnormal stress test.Results noted no coronary artery disease, normal left ventricular function and a 40% right common femoral artery stenosis, most likely the result of spasm.Approximately twelve years and six months after the index procedure a renal ultrasound was performed for microscopic hematuria and renal cysts.Results of the scan noted stable bilateral simple renal cysts (congenital), no hydronephrosis.Approximately thirteen years and three months after the index procedure the patient was seen in referral for chronic deep vein thrombosis (dvt) of the rle and requested a venogram to evaluate the right leg pain.Approximately eighteen years and two weeks after the index procedure the patient was seen in consultation for rle dvt maintenance.A referral for vena caval filter removal was made at that time.Approximately nineteen years and four months after the index procedure the patient had a consultation for filter removal.The consult noted that the patient had intractable abdominal symptoms.Review of a computed tomography scan noted the vena cava filter appeared to be protruding from the inferior vena caval wall.After discussion with the patient it was recommended that the filter be surgically removed.The filter was removed one month later.Additional information received per the patient profile form states that the patient experienced perforation of filter struts into organs, migration of the entire filter other than to the heart, filter embedded, blood clots, clotting and/or occlusion of the ivc, and loss of blood requiring a blood transfusion.The patient became aware of the reported events approximately nineteen years and four months after the index procedure.The filter was reportedly removed via an open abdominal procedure approximately nineteen years and five months after the index procedure the patient also reported anxiety and severe pain related to the migration of the filter.

• 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: 12298933
• MDR Text Key: 265782384
• Report Number: 1016427-2021-05262
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/28/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN 18 GAUGE NEEDLE; UNKNOWN 5 FR SHEATH; UNKNOWN DELIVERY SHEATH; UNKNOWN GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 34 YR
• Patient Weight: 111