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

Catalog Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Swelling (2091); Thrombosis (2100); Ulcer (2274); No Code Available (3191)

Event Date 04/03/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to a thrombosed inferior vena cava (ivc) filter with collaterals, recurrent deep vein thrombosis (dvt), occluded ivc (re-canalized and stented).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 results, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) review could be performed.The inferior 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 that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Deep vein thrombosis (dvt) occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency, possibly leading to lower extremity pain and swelling.Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities.The presence of these clots do not represent a device malfunction.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation of the device; therefore no corrective action will be taken.

Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to a thrombosed inferior vena cava (ivc) filter with collaterals, recurrent deep vein thrombosis (dvt), occluded ivc (re-canalized and stented).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 results, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.

Manufacturer Narrative

Section b5: addendum for additional information received: per the information received in the medical records, the patient has a history of deep vein thrombosis (dvt), pulmonary embolism (pe), therapeutic anticoagulation, depression, anxiety disorder, alcohol use, hypertension, hyperlipidemia, esophageal wall thickening, chronic bronchitis, congestive heart failure (chf) and leg cellulitis.Prior to the filter placement procedure, the patient presented to the hospital with an inr of 3.4 and being hypoxic.The patient underwent filter placement due to evidence of bilateral pe following a computed tomography (ct) scan, considered mild clot in the right upper lobe, pulmonary artery mild to moderate amount of clot at the junction between the left upper and left lower lobe pulmonary arteries.The filter was placed without complication and the hypoxia resolved spontaneously.The patient is noted to be continuing with anticoagulation therapy.Approximately six years and six months post implantation, the patient was admitted for chronic atrial fibrillation with pacemaker implantation.Approximately eight months and twenty-one days after, the patient presented for thrombosed filter and development of collaterals, right lower extremity (rle) venous stasis ulcers.The procedure included inferior venocavagram, bilateral lower extremity venogram, re-canalization of occluded bilateral iliocaval system with placement of a stent across occluded ivc filler, bilateral common iliac venous deployment of stent, bilateral stent deployment, right common femoral stent deployment, and intravascular ultrasound.Occluded ivc successfully re-canalized and stented.The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the alleged failures approximately seven years and three months post implantation.The patient reports to have blood clots, clotting and/or occlusion of the ivc, which caused the collaterals and the re-canalization and stenting of the ivc.The patient also reports constant pain and leg swelling.As reported, the patient had placement of an optease inferior vena cava (ivc) filter.Per the medical records, history includes deep vein thrombosis (dvt), pulmonary embolism (pe), therapeutic anticoagulation, depression, anxiety disorder, alcohol use, hypertension, hyperlipidemia, esophageal wall thickening, chronic bronchitis, congestive heart failure (chf) and leg cellulitis.The patient presented an inr of 3.4 and hypoxic.The indication for filter was bilateral pe, the ct showed mild clot in the right upper lobe, pulmonary artery mild to moderate amount of clot at the junction between the left upper and left lower lobe pulmonary arteries.The filter was placed without complication and the hypoxia resolved spontaneously.The patient is noted to be continuing with anticoagulation therapy.The filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to a thrombosed inferior vena cava (ivc) filter with collaterals, recurrent deep vein thrombosis (dvt), occluded ivc (re-canalized and stented).Approximately six years and six months post implantation, the patient was admitted for chronic atrial fibrillation with pacemaker implantation.Approximately eight months and twenty-one days after, the patient had thrombosis of the filter, development of collaterals, and right lower extremity (rle) venous stasis ulcers.An inferior venocavagram, bilateral lower extremity venogram, re-canalization of occluded bilateral iliocaval system with placement of a stent across occluded ivc filler, bilateral common iliac venous deployment of stent, bilateral stent deployment, right common femoral stent deployment, and intravascular ultrasound was done.Per the patient profile form (ppf), the patient reports blood clots, clotting and/or occlusion of the ivc, which caused the collaterals and the re-canalization and stenting of the ivc.The patient also reports constant pain and leg swelling.The product was not returned for analysis and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) review could be performed.The optease 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.Collateral circulation, venous stasis ulcer and swelling of the legs do not represent a device malfunction.Pain does 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.Section h6: patient code '3191' was used as there is no code available for 'collateral circulation'.

• 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: 8359541
• MDR Text Key: 136800904
• Report Number: 1016427-2019-02535
• 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,other
• Type of Report: Initial,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR