MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETR FILTER 55 FEMORAL; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F220AF

Device Problem Failure to Align (2522)

Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter had tilted and was associated with deep vein thrombosis (dvt) and pulmonary embolism (pe).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 optease retrievable vena cava filter is indicated for use in the prevention of recurrent pe via percutaneous placement in the inferior vena cava (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.Without images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called dvt.A 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.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).This event does not represent a malfunction of the device.Recurrent pe is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.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 in the legal brief, a 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, post implant deep vein thrombosis (dvt) pulmonary embolism (pe) and tilting of the inferior vena cava (ivc) filter.As a direct and proximate result of the malfunction of her filter, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress and other damages.

Event Description

As reported in the legal brief, a 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, post implant deep vein thrombosis (dvt) pulmonary embolism (pe) and tilting of the inferior vena cava (ivc) filter.As a direct and proximate result of the malfunction of her filter, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress and other damages.Per the implant records, the filter was indicated for acute right lower extremity extensive deep venous thrombosis (dvt), acute bilateral pulmonary embolism (pe), acute right lower extremity cellulitis, acute right lower extremity leg pain and history of lower extremity dvt.The patient underwent thrombolysis and insertion of the inferior vena cava (ivc) filter.An optease femoral 55cm ivc filter was inserted via the left common femoral vein and deployed.Approximately seven months after the filter was implanted, a computed tomography (ct) scan was indicated for an unspecified injury to the inferior vena cava.The ct findings reported an optease or similar type ivc filter present, well positioned, located approximately 1cm below the right renal vein.There is a small degree of filter tilt measuring approximately 8 degrees with the caudal apex/hook of the filter touching the anterior ivc wall without visualized protrusion or perforation.The cranial portion of the filter approximates the ivc wall within 2 mm but without contact.A partially visualized right external iliac vein stent also noted.Additional findings included a thickened appearance of the distal esophagus as well as a few mildly enlarged para esophageal lymph nodes; hepatomegaly with steatosis; a small fat-containing umbilical hernia and moderate diverticulosis of the visualized colon without evidence of diverticulitis.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately eight months post implantation.The patient reports tilting of the filter, blood clots, clotting and or occlusion of the ivc.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was reported to be for acute bilateral pulmonary embolism (pe), acute and extensive right lower extremity deep vein thrombosis (dvt) with acute cellulitis and pain in the setting of a history of lower extremity dvt.The patient underwent thrombolysis prior to the implantation of a filter via the left common femoral vein.Approximately seven months after the filter implantation, the patient underwent a computerized tomography (ct) scan for an unspecified injury.The ct scan noted a well-positioned filter located approximately 1cm below the right renal vein.The filter was tilted approximately eight-degrees with the caudal hook touching the anterior wall of the inferior vena cava (ivc) and the cranial aspect approximately 2mm from the ivc wall.The patient further reported dvt, pe, blood clots, clotting and/or occlusion of the ivc.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 optease retrievable vena cava filter is indicated for use in the prevention of recurrent 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.Without images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called dvt.A 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.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.These events do not represent a malfunction of the device.Recurrent pe is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Stenosis, blood clots, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.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.

• Brand Name: OPTEASE RETR FILTER 55 FEMORAL
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9525909
• MDR Text Key: 174365090
• Report Number: 1016427-2019-03703
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466F220AF
• Device Catalogue Number: 466F220AF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRITE TIP CATHETER SHEATH INTRODUCER; UNK 6F SLENDER; UNK GLIDESHEATH; UNK GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 54 YR