MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Chest Pain (1776); Embolus (1830); Occlusion (1984); Swelling (2091); Stenosis (2263); Vascular System (Circulation), Impaired (2572)

Event Date 09/20/2007

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received, it will be provided.Complaint conclusion: as reported, the patient underwent placement of the trapease vena cava filter.The indication for the filter placement was not reported.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, emotional and physical damages from 95 percent inferior vena cava (ivc) stenosis associated with the filter.The implanted filter is reported to pose a progressive risk of perforation of the vena cava and surrounding vital organs vessels and structures which can result in severe pain and life-threatening complications.It also poses an increased and progressive risk of migration, fractures.Embolization of a fracture, and thrombosis/clotting causing serious injury and death.The patient is forced to live with the possibility that these complications can happen at any moment which has led to severe fear stress anxiety and loss of enjoyment of life.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.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 ivc 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 of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective ivc filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, emotional and physical damages from ninety-five percent inferior vena cava (ivc) stenosis associated with the ivc filter.The implanted filter noses in progressive risk of perforation of the vena cava and surrounding vital organs vessels and structures which can result in severe pain and life-threatening complications.It also poses an increased and progressive risk of migration, fractures.Embolization of a fracture, and thrombosis/clotting causing serious injury and death.The patient is forced to live with the possibility that these complications can happen at any moment which has led to severe fear stress anxiety and loss of enjoyment of life.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

As reported, the patient had placement of the trapease inferior vena cava (ivc) filter.Per the medical records, history includes congestive heart failure, coronary artery disease with stents, wheelchair bound at the time of hospital admission, hypertension, multiple deep vein thrombosis, stents in right kidney for hematuria, gastrointestinal bleed, bloody sputum, pulmonary embolism and obesity.The indication for filter placement was deep venous thrombosis with gastrointestinal bleeding.The filter was deployed above the iliac bifurcation and below the renal veins on the l3-l4 interspace level.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, emotional and physical damages from ninety-five percent inferior vena cava (ivc) stenosis associated with the ivc filter.Three years and one months after the index procedure, a bilateral venogram was done.It revealed chronic bilateral external iliac vein occlusion.The right venogram demonstrates no cross-filling into the left side of the body whereas the left venogram does demonstrate collateral filling on the right side.The patient's right-sided abdominal pain, therefore, may be explained by venous congestion of right-sided collateral veins.The results of computed tomography (ct) scans done approximately three years and ten months after the index procedure indicate dependent atelectasis, local stranding opacity periphery lung base, nodular density in the right lung base, mild degenerative change in the spine, mild aneurysmal dilatation of ascending aorta, stranding of anterior mediastinal fat, prominent left supramediastinal lymph node and hiatal hernia.Four years after the index procedure, the patient experienced a cerebrovascular accident with residual left side weakness.The results of an angiogram done approximately four years and ten months after the index procedure revealed high-grade stenosis of inferior vena cava associated with the filter.The records also noted that the patient has a history of deep vein thrombosis and pulmonary embolism.There was an unsuccessful attempt to remove the permanent filter.Fourteen years and five months after the index procedure, the patient was admitted for chest pain and treated medically.Per the patient profile form (ppf), the patient reports blood clots, clotting and/or occlusion of the inferior vena cava (ivc), ivc stenosis, multiple collateral veins/vessels, venous congestion, leg pain and leg swelling.It was also reported that the patient experienced fear, stress, anxiety and loss of enjoyment of life.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 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.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Collateral circulation, swelling of legs, cerebrovascular accident, and chest pain and known potential adverse events associate to the use of the cordis filter devices.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Permanent ivc filters have been reported to obstruct in up to 20% of patients.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.

Manufacturer Narrative

Section d4: a copy of the label provided the catalog number; however, the lot number was illegible.Section e3: occupation: other, senior counsel, litigation.Section h6: patient code '1984' was used for 'inferior vena caval occlusion and venous occlusion.' section h6: patient code '2572' was used for 'collateral circulation.' section b5: additional information received per the medical records indicate that the patient has a history of congestive heart failure, coronary artery disease with stents, wheel chair bound at the time of hospital admission, hypertension, multiple deep vein thrombosis, stents in right kidney for hematuria, gastrointestinal bleed, bloody sputum, pulmonary embolism and obesity.The indication for filter placement was deep venous thrombosis with gastrointestinal bleeding.The filter was deployed via the patient's right femoral vein.It was placed above the iliac bifurcation and below the renal veins on the l3-l4 interspace level.The patient tolerated the procedure well.  three years and one months after the index procedure, a bilateral venogram was done.It revealed chronic bilateral external iliac vein occlusion.The right venogram demonstrates no cross-filling into the left side of the body whereas the left venogram does demonstrate collateral filling on the right side.The patient's right-sided abdominal pain, therefore, may be explained by venous congestion of right-sided collateral veins.The results of computed tomography (ct) scans done approximately three years and ten months after the index procedure indicate dependent atelectasis, local stranding opacity periphery lung base, nodular density in the right lung base, mild degenerative change in the spine, mild aneurysmal dilatation of ascending aorta, stranding of anterior mediastinal fat, prominent left supramediastinal lymph node and hiatal hernia.Four years after the index procedure, the patient experienced a cerebrovascular accident with residual left side weakness.The results of an angiogram done approximately four years and ten months after the index procedure revealed high-grade stenosis of inferior vena cava associated with the filter.The records also noted that the patient has a history of deep vein thrombosis and pulmonary embolism.There was an unsuccessful to remove the permanent filter.Fourteen years and five months after the index procedure, the patient was admitted for chest pain.The patient was treated medically.Additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting and/or occlusion of the inferior vena cava (ivc), ivc stenosis, multiple collateral veins/vessels, venous congestion, leg pain and leg swelling.It was also reported that the patient experienced fear, stress, anxiety and loss of enjoyment of life.Additional information is pending and will be submitted within 30 days of receipt.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8430482
• MDR Text Key: 139164872
• Report Number: 1016427-2019-02628
• 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
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2005
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0402068
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 18 GAUGE NEEDLE; UNKNOWN DILATOR; UNKNOWN GUIDE WIRE; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR