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

Catalog Number 466P306X

Device Problems Bent (1059); Kinked (1339); Difficult to Remove (1528); Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Perforation (2001); Swelling (2091); Thrombosis (2100); Perforation of Vessels (2135); Vascular System (Circulation), Impaired (2572); No Code Available (3191)

Event Date 04/15/2011

Event Type  Injury  

Manufacturer Narrative

The exact implant date is not known but the filter was implanted on or about (b)(6) 2003.As reported, the patient underwent a surgical procedure to implant a trapease inferior vena cava (ivc) filter for the treatment of deep venous thrombosis.The device was implanted into the renal veins by the physician.The device in the patient was positively identified by the patients¿ medical records.Approximately eight years, three months post implant, the patient received an exam on his abdomen and pelvis which showed extensive ivc thrombosis, the ivc filter was also noted in the medical records as bent and tilted with calcification.Approximately five days later, the patient received an exam on his abdomen and pelvis at which showed that the ivc filter appeared seated within the vena cava, a clot in the center and extends into the bilateral common iliac veins as well as into the left external iliac, left common femoral, left superficial veins.As a result of the malfunctioned trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The trapease 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 and occlusion of the ivc filter does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Calcification is the accumulation of calcium salts in a body tissue.It is transported through the blood stream.Calcification normally occurs in the formation of bone, but calcium can be deposited abnormally in any part of the body, causing it to harden.Calcification within a patient does not represent a device malfunction.Without images or procedural films for review, the reported filter tilt and bent condition could not be confirmed and the exact cause could not be determined.Additionally, the timing and mechanism of the reported filter tilt is unknown.Patient, technique or procedural factors may have contributed to the reported tilt given the limited information available for review at this time, 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 by the legal brief, the patient underwent a surgical procedure to implant a trapease¿ filter for the treatment for deep venous thrombosis.The device was implanted into the renal veins by the physician.The device in the patient was positively identified by the patients¿ medical records.Approximately eight years, three months post implant the patient received an exam on his abdomen and pelvis which showed extensive inferior vena cava (ivc) thrombosis, his ivc filter was noted in the medical records as bent and tilted with calcification.Approximately five days later the patient received an exam on his abdomen and pelvis at which showed that the inferior vena cava (ivc) filter appeared seated within the vena cava with a clot in the center and extends into bilateral common iliac veins as well as into the left external iliac, left common femoral, left superficial veins.As a result of the malfunction of the malfunctioned trapease¿ filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: date of report, pma/510k, type of reportable event and if follow-up what type.As reported, the patient had implant of a trapease inferior vena cava (ivc) filter for the treatment for deep venous thrombosis.The patient history includes type 2 diabetes mellitus, asthma, venous insufficiency, high cholesterol, peri-rectal abscess, sleep apnea on continuous positive airway pressure, gastroesophageal reflux disease and barrett¿s esophagus, cholecystectomy complicated with deep vein thrombosis (dvt), pulmonary embolism (pe).One month prior to implant, the patient had an esophagogastrectomy.Per the medical records, indication was bilateral lower extremity dvt and an inability to continue with anticoagulation therapy.There was gastrointestinal (gi) bleeding post esophagpgastrectomy.The filter deployed in an infrarenal position above the iliac bifurcation.The patient tolerated the procedure well.Two months after the index procedure, the patient underwent an esophagogastroduodenoscopy (egd) and was treated with botox injections of the sphincter.Approximately eight years, three months post implant, a scan revealed extensive inferior vena cava (ivc) thrombosis, bent and tilted with calcification.Approximately five days later another scan revealed that the inferior vena cava (ivc) filter appeared seated within the vena cava with a clot in the center and extending into bilateral common iliac veins as well as into the left external iliac, left common femoral, left superficial veins.Per the patient profile form (ppf), the patient reports a failed thrombectomy in 2011, after having developed a dvt and clot within the filter.In addition, the patient reported blood clots, clotting and/or occlusion of the ivc.In 2016, the patient was told that the filter was not working correctly.In 2017, the patient underwent a ct scan that revealed that the filter had tilted, was bent and was associated with a perforation of the filter strut(s) outside of the ivc and into the aortic and mesenteric vasculature.The patient further reported that there had been an attempt to retrieve the filter but was unable to provide further documentation or details.In addition, the patient reported that the filter had bent struts and calcification.The patient further reported having mood swings, difficulty concentrating, loss of focus, depression and anxiety.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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Vascular calcification, while not specifically listed in the ifu, is a known potential event associated with the placement of the ivc filter device.The body produces an immune response to all foreign objects implanted, and calcification is one of those known reactions.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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.

Manufacturer Narrative

Correction to product code.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis, a cholecystectomy, pulmonary embolism, bi-polar disorder, obesity and sleep apnea.Prior to the index procedure the patient underwent an esophagogastrectomy for esophageal cancer and developed a gastrointestinal bleed after being restarted on anticoagulation therapy.Subsequently, the patient was implanted with the inferior vena cava filter.Approximately eight years and ten weeks after the index procedure, the patient presented to the hospital with acute left lower extremity pain and swelling.An ultrasound was notable for a deep vein thrombosis from the common femoral vein through the calf of the left leg.The patient was started on anticoagulation therapy and discharged.Approximately eight years and twelve weeks after the index procedure, the patient presented to the hospital with left leg pain and swelling.A computed tomography (ct) scan showed significant thrombus along the length of the left lower extremity with evidence of calcification of the pre-existing thrombus along the length of the leg extending into the inferior vena cava up to the level of the ivc filter.The scan also noted that the filter was bent/tilted and the patient had a large hiatal hernia.A thrombectomy was attempted, but access could not be achieved due to mostly hard chronic clot.Approximately eight years and four months after the index procedure, the patient presented to their doctor for follow-up of massive deep vein thrombi, postphlebitic syndrome and phlegmesia.A duplex ultrasound evaluation, performed at that time noted chronic occlusive thrombus of the left lower extremity, the only obvious patent vessel on the left was the greater saphenous vein, the right common femoral vein showed no thrombus.Additional information received per the patient profile form (ppf) states that the patient experienced tilting of the filter, inferior vena cava thrombosis.The patient became aware of the reported events eight years and three months after the index procedure.The form states that the patient has also experienced upper gastrointestinal bleeding, anxiety, fear, fatigue, pain and suffering.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

Section h6: patient code '2572' was used for 'aortic atherosclerotic.' section h6: patient code '1984' was used for 'device occlusion and occlusion of the inferior vena cava.' section b5: the patient had a long history of type 2 diabetes mellitus, asthma, venous insufficiency, high cholesterol, peri-rectal abscess, sleep apnea on continuous positive airway pressure, gastroesophageal reflux disease and barrett¿s esophagus.Nineteen years before the index procedure, the patient underwent a cholecystectomy with a subsequent deep vein thrombosis (dvt).Six years before the index procedure, the patient developed a pulmonary embolism (pe)from an unknown cause.In addition, the patient had undergone an esophagogastrectomy during the month before the index procedure.The medical records revealed that the filter was implanted for a history of bilateral lower extremity dvt and an inability to continue with anticoagulation therapy in light of the patient¿s gastrointestinal bleeding episodes.The gastrointestinal (gi) bleeding was thought to have been associated with the recent gi surgery.Laboratory testing revealed anemia and a supratherapeutic international normalized ratio (inr).The treatment was an adjustment of the patient¿s anticoagulation therapy.The patient was also treated with fresh frozen plasma and packed cells.The patient underwent an esophagoduodenostomy (egd) on which revealed significant esophagitis.A decision was made to discontinue the patient¿s anticoagulation therapy subsequently the patient was implanted with the inferior vena cava filter (ivf).The right common femoral vein was initially cannulated but was found to be fibrotic with evidence of thrombus in the right iliac vein.The left common femoral vein was then accessed; and the filter deployed in an infrarenal position above the iliac bifurcation.The patient tolerated the procedure well.  the patient was admitted to hospital on the following month with gi bleeding.Laboratory testing revealed a supratherapeutic inr while on coumadin.The most likely cause of the bleeding was thought to be continued reflux leading to esophagitis and esophageal bleeding.The patient was treated with intravenous fluid and dietary restrictions.The patient underwent an egd which revealed no evidence of anastomotic ulcer and the patient was discharged home later that day.Two months after the index procedure, the patient underwent an egd and was treated with botox injections of the sphincter.Three months after the index procedure the patient was admitted to hospital with a one-day history of soft, black, tarry stools that had increased in amount and frequency along with complaints of fatigue, reflux, weight loss and chills.The patient further reported having had dark stools with blood since the esophageal surgery.The patient was discharged after two days.Approximately three months and two weeks after the index procedure, the patient presented to the hospital with left lower extremity swelling and pain over the last three weeks.The patient was noted to have diffuse tenderness, venous congestion and left leg swelling.A computerized tomography (ct) scan revealed diffuse dvts in the left common femoral, superficial femoral, popliteal, saphenous and calf veins.This thrombus was seen to extend into the ivc to the level of the ivc filter.Multiple attempts to access the patient¿s venous system in the endovascular suite were unsuccessful and the procedure was terminated.The patient was treated with a heparin infusion and the leg wrapped.After the second day of hospitalization, the patient underwent a repeat ct scan that revealed a large hiatal hernia and an infrarenal ivc with clot in the center that extended bilaterally into the common iliacs, the left external iliac, left common femoral and left superficial femoral veins.The patient was later discharged to a rehabilitation facility.Five months after the index procedure, the patient underwent a kidney-ureter-bladder (kub) study to evaluate the location of an endoscopy capsule that had been ingested the week before.This study revealed surgical clips in the right upper quadrant and an inferior vena cava (ivc) filter at the l3-l4 level.The endoscopy capsule was not seen.Approximately four years and nine months after the index procedure, the patient underwent an abdominal ct scan that revealed that the filter had tilted and was seated asymmetrically within the ivc lumen with the apex directed laterally and contacting the anterolateral wall roughly 1.1cm inferior to the lowest renal vein.The inferior aspect of the filter was directed medially and overlies the posterior medial wall.All six of the filter struts extended beyond the lumen of the ivc with two of the anterior struts overlapping the posterior margin of the third segment of the duodenum and two struts overlying the surrounding fat.In addition, there was questionable evidence of the medial strut with the wall of the aorta and the lateral strut with the wall of the right gonadal vein.Irregularity of the internal structures of the filter were also noted; particularly medially with smooth bending but no significantly angulated fractures or step-off.Limited evaluation of the ivc lumen showed no evidence of abrupt caliber changes.The study also demonstrated abdominal aortic atherosclerotic calcifications with dense calcification of the bilateral renal artery origins.Additional information received per an amended patient profile form (ppf) states that eight years after the index procedure the patient experienced a failed thrombectomy after having developed a dvt and clotting within the filter.Approximately thirteen years after the index procedure, the patient became aware that the filter was not working correctly.Approximately fourteen years after the index procedure, the patient underwent a ct scan that revealed that the filter had tilted, was bent and was associated with a perforation of the filter strut(s) outside of the ivc and into the aortic and mesenteric vasculature.The patient further reported that there had been an attempt to retrieve the filter but no further documentation or details were provided.In addition, the patient reported that the filter had bent struts and calcification.The patient further reported having blood clots, clotting and/or occlusion of the ivc, mood swings, difficulty concentrating, loss of focus, depression and anxiety.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

Section h6: patient code '3191' was used was there are no codes available for 'postphlebitic syndrome and phlegmasia'.Section b5: as reported, the patient had implant of a trapease inferior vena cava (ivc) filter for the treatment for deep venous thrombosis.Per the medical records, the patient has a history of deep vein thrombosis, a cholecystectomy, pulmonary embolism, bi-polar disorder, obesity and sleep apnea.Prior to the index procedure the patient underwent an esophagogastrectomy for esophageal cancer and developed a gastrointestinal bleed after being restarted on anticoagulation therapy.Subsequently, the patient was implanted with the inferior vena cava filter.Approximately eight years, three months post implant the patient had a scan of the abdomen and pelvis which showed extensive inferior vena cava (ivc) thrombosis, it was noted that the filter was bent and tilted with calcification.Another scan 5 days later, showed the inferior vena cava (ivc) filter appeared seated within the vena cava with a clot in the center and extends into bilateral common iliac veins as well as into the left external iliac, left common femoral, left superficial veins.Approximately eight years and ten weeks after the index procedure, the patient presented to the hospital with acute left lower extremity pain and swelling.An ultrasound was notable for a deep vein thrombosis from the common femoral vein through the calf of the left leg.The patient was started on anticoagulation therapy and discharged.Approximately eight years and twelve weeks after the index procedure, the patient presented to the hospital with left leg pain and swelling.A computed tomography (ct) scan showed significant thrombus along the length of the left lower extremity with evidence of calcification of the pre-existing thrombus along the length of the leg extending into the inferior vena cava up to the level of the ivc filter.The scan also noted that the filter was bent/tilted and the patient had a large hiatal hernia.A thrombectomy was attempted, but access could not be achieved due to mostly hard chronic clot.Approximately eight years and four months after the index procedure, the patient presented to their doctor for follow-up of massive deep vein thrombi, postphlebitic syndrome and phlegmasia.A duplex ultrasound evaluation, performed at that time noted chronic occlusive thrombus of the left lower extremity, the only obvious patent vessel on the left was the greater saphenous vein, the right common femoral vein showed no thrombus.Per the patient profile form (ppf), the patient experienced tilting of the filter, inferior vena cava thrombosis.The patient became aware of the reported events eight years and three months after the index procedure.The form states that the patient has also experienced upper gastrointestinal bleeding, anxiety, fear, fatigue, pain and suffering.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.Kink/bent deformation of the device is a known potential event associated with use of the ivc filters, the ivc is a dynamic vessel subject to ongoing physical stressed and this and impact the shape of the filter struts over time.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Blood clots, post phlebotic syndrome, swelling of the legs and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety and pain do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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 VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 6980890
• MDR Text Key: 90392581
• Report Number: 1016427-2017-00711
• 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,Followup,Followup,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• 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: 05/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR