MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE FEMORAL 55 CM KIT; VENA CAVA FILTER

Model Number N/A

Device Problem Occlusion Within Device (1423)

Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Occlusion (1984); Thrombosis (2100)

Event Date 04/30/2014

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is an optease filter and for which the catalog and lot numbers are not currently available.If obtained, a follow up report will be submitted within 30 days upon receipt.As reported in the legal brief (b)(6), the patient underwent placement of an optease filter which reportedly malfunctioned and caused injuries and damages to the patient including, but not limited to, pulmonary emboli, chest pain, extensive dvt, caval thrombosis, ivc thrombosis, and chronic occlusion of the filter.As a direct and proximate result of these malfunctions, 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.A review of the manufacturing records could not be conducted without a lot number.The optease 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.Pulmonary emboli, chest pain, extensive dvt, caval thrombosis, ivc thrombosis, and chronic occlusion of the filter do not represent a device malfunction.The reported pulmonary emboli, chest pain, extensive dvt, caval thrombosis, ivc thrombosis, and chronic occlusion of the filter could not be confirmed without films for review.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.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.

Event Description

As reported in the legal brief (b)(6), the patient underwent placement of an optease filter which reportedly malfunctioned and caused injuries and damages to the patient including, but not limited to, pulmonary emboli, chest pain, extensive dvt, caval thrombosis, ivc thrombosis, and chronic occlusion of the filter.As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

Additional information was received: when the initial filter was placed, the patient presented with shortness of breath and pain in the right leg.The preoperative diagnosis was massive thromboembolism with residual deep venous thrombosis.The inferior vena cava filter (ivc) filter was placed in the renal veins.The patient tolerated the procedure well.Ivc removal was planned for when the patient has hemodynamically stabilized.Additional information pending and will be submitted within 30 days upon receipt.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1016427-2017-00556 and 9616099-2018-02122.

Manufacturer Narrative

Additional information received per the patient profile form (ppf) indicates that the patient had blood clots, clotting, blood clots in the legs and occlusion of the ivc.Twenty-nine days post implantation the first filter placed was successfully removed percutaneously.A year and a month post the first filter removal a computerized tomography (ct) scan revealed multiple right pulmonary emboli.According to the information received in the medical records, a second optease filter was implanted a year and a month post implant of the first filter.The filter was placed due to the patient¿s recurrent pe and being unable to tolerate xarelto.During the implantation procedure of the second filter, the filter was deployed via the femoral vein in the renal veins with usual pullback fashion without any reported complications.A follow-up venography of the ivc filter showed excellent deployment.The patient has a history of previous pe, dvt with thromboembolism, chest pain, asthma, chronic obstructive pulmonary disease (copd), shortness of breath (sob), leiden factor v deficiency, gout, hypertension, pneumonia, sleep apnea, insomnia and edema.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The patient has a history of previous pe, dvt with thromboembolism, chest pain, asthma, chronic obstructive pulmonary disease (copd), shortness of breath (sob), leiden factor v deficiency, gout, hypertension, pneumonia, sleep apnea, insomnia and edema.The optease filter was implanted without report of complications.Twenty-nine days post implantation of the first filter, the filter was successfully removed percutaneously.A year and a month post the first filter removal a computerized tomography (ct) scan revealed multiple right pulmonary emboli.According to the information received in the medical records, a second optease filter was implanted a year and a month post implant of the first filter.The filter was placed due to the patient¿s recurrent pe and being unable to tolerate xarelto.During the implantation procedure of the second filter, the filter was deployed via the femoral vein in the renal veins with usual pullback fashion without any reported complications.A follow-up venography of the ivc filter showed excellent deployment.The device reportedly malfunctioned, causing injuries to the patient including, but not limited to, pulmonary emboli (pe), chest pain, extensive deep vein thrombosis (dvt), caval thrombosis, inferior vena cava (ivc) thrombosis, and chronic occlusion of the filter.Per the patient profile form (ppf), the patient had blood clots, clotting, blood clots in the legs and occlusion of the ivc.The second filter remains implanted; thus, unavailable for analysis.The products were not returned for analysis and the sterile lot numbers have not been provided; therefore, no device analysis nor device history record 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, pulmonary emboli, clotting and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Chest 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.This is one of two products involved with the reported event and the associated manufacturer report numbers are 9616099-2018-02122.

Manufacturer Narrative

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the medical records received, the patient presented with shortness of breath and pain in the right leg.The preoperative diagnosis was massive thromboembolism with residual deep venous thrombosis.An inferior vena cava filter (ivc) filter was placed in the renal veins.The patient tolerated the procedure well.Ivc removal was planned for when the patient has hemodynamically stabilized.The patient has a history of previous pe, dvt with thromboembolism, chest pain, asthma, chronic obstructive pulmonary disease (copd), shortness of breath (sob), leiden factor v deficiency, gout, hypertension, pneumonia, sleep apnea, insomnia and edema.The device reportedly malfunctioned and caused injuries and damages to the patient including, but not limited to, pulmonary emboli (pe), chest pain, extensive deep vein thrombosis (dvt), caval thrombosis, inferior vena cava (ivc) thrombosis, and chronic occlusion of the filter.Per the patient profile form (ppf), the patient had blood clots, clotting, blood clots in the legs and occlusion of the ivc.Twenty-nine days post implantation the first filter placed was successfully removed percutaneously.A year and one month post the first filter implant a computerized tomography (ct) scan revealed multiple right pulmonary emboli.Per the medical records, a second optease filter was implanted a year and a month post implant of the first filter.The filter was placed due to the patient¿s recurrent pe and being unable to tolerate xarelto.During the implantation procedure of the second filter, the filter was deployed via the femoral vein in the renal veins with usual pullback fashion without any reported complications.A follow-up venography of the ivc filter showed excellent deployment.The filters remain implanted; thus, unavailable for analysis.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 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, pulmonary embolism and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Chest 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.Should additional information become available, the file will be updated accordingly.This is one of two products involved with the reported event and the associated manufacturer report numbers are (b)(4).

• Brand Name: OPTEASE FEMORAL 55 CM KIT
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami lakes FL ; EI
• MDR Report Key: 6807618
• MDR Text Key: 83150378
• Report Number: 1016427-2017-00556
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466F220A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/31/2017
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 76