MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466FXXXX

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

Patient Problems Pulmonary Embolism (1498); Hemorrhage/Bleeding (1888); Occlusion (1984); Respiratory Distress (2045); Thrombosis (2100)

Event Date 02/13/2015

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the patient underwent placement of defendants' optease vena cava filter on or about (b)(6) 2014.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, recurrent blood clots, asymmetric pulmonary hemorrhage; internal bleeding, recurrent deep vein thrombosis (dvt), and respiratory distress.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, and pain and suffering, and other damages.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 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 within the filter, asymmetric pulmonary hemorrhage; internal bleeding and respiratory distress does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).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 manufacturing process of the device; therefore no corrective action will be taken.Should additional information become available, the file will be updated accordingly.  implant date: on or about (b)(6) 2014.

Event Description

As reported by the legal brief, the patient underwent placement of defendants' optease vena cava filter on or about (b)(6) 2014.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, recurrent blood clots, asymmetric pulmonary hemorrhage; internal bleeding, recurrent deep vein thrombosis (dvt), and respiratory distress.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, and pain and suffering, and other damages.

Manufacturer Narrative

The following additional information received per the medical records indicate that the patient has a history of morbid obesity and deep vein thrombosis (dvt).The patient underwent the filter placement due to an impending knee surgery.During the implantation procedure, the filter was successfully deployed.According to the information received in the patient profile form (ppf), the patient became aware of the reported events nine months and fifteen days post implantation.The patient reports to have clotting and occlusion of the inferior vena cava (ivc), pulmonary embolism (pe) and alveolar hemorrhage.The patient also reports to have pain and be suffering from anxiety.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, recurrent blood clots, asymmetric pulmonary hemorrhage, internal bleeding, recurrent deep vein thrombosis (dvt), and respiratory distress.According to the information received, the patient became aware of the reported events nine months and fifteen days post implantation.The patient is reported to have clotting and occlusion of the inferior vena cava (ivc), pulmonary embolism (pe) and alveolar hemorrhage.The patient is also reported to have experienced pain and anxiety.The indication for the filter implant was a morbidly obese patient with a dvt that was scheduled for knee surgery.A retrievable ivc filter was indicated perioperatively.The device was placed via the right common femoral vein, angiography was performed and showed a normal size vein and the left renal vein was located.The filter was successfully deployed under fluoroscopic guidance.There is currently no additional information available.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 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 that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency, resulting in swelling/edema/bulging of the effected extremity(s).Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Blood clots and thrombosis within the filter do not represent a device malfunction.Without the procedural films or post-placement imaging and the limited information provided, the report of blood clots, asymmetric pulmonary hemorrhage, internal bleeding, recurrent deep vein thrombosis (dvt), and respiratory distress clotting could not be confirmed or further clarified, nor can a conclusion about a relationship between the reported events and the filter be drawn.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road cashel, co.; tipperary ; EI
• MDR Report Key: 6656971
• MDR Text Key: 78067124
• Report Number: 1016427-2017-00378
• 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,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6 FRENCH SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 59 YR