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

Model Number 466FXXXX

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

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Blood Loss (2597)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown; stated as 2015.The catalog number is unknown, if received it will be provided.Complaint conclusion: 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 caval thrombosis and deep vein thrombosis (dvt).The indication for the filter implant was not provided and there is currently no additional information available for review.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, clotting and/or occlusive thrombosis or occlusion within the filter and/or the vasculature do not represent a device malfunction.Ivc filters are not indicated for use in the prevention of dvt.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.With the limited information provided the reported event(s) could not be confirmed or further clarified.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.

Event Description

As reported by the legal brief, the patient underwent placement of a optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: dvt, caval thrombosis.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

Additional information was provided and is available in: section a2 (age at the time of event, date of birth) section b3 (event date) section b4 (event description) section b7 (relevant medical history) section d11 (concomitant medical products - 6-french fogarty balloon, possis angiojet, penumbra catheter, betadine-soaked kerlix, ace wraps, esmarch) section g4 (date received by the manufacturer) section h6 (evaluation codes) complaint conclusion: as reported, the patient had placement of an optease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages including, but not limited to dvt, caval thrombosis.Per the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc, and dvt.Per the medical records, at an unknown time post optease implant, the patient was admitted with a gi bleed.After conservative treatment, the patient regressed and developed phlegmasia and tissue compromise.The patient had a right and left groin exploration with mechanical thromboembolectomy of the ivc, bilateral common and external iliac veins and common femoral vein.There was unsuccessful thrombectomy of the filter.Bilateral lower leg dissection was carried down to the lateral and anterior compartments, where fasciotomies were performed.After initial balloon thromboembolectomy there was still noted to be significant amount of clot burden.After balloon thromboembolectomy with a larger balloon, the ivc, common and external iliac arteries were patent with much less clot burden except for within the ivc filter.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, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.

Event Description

As reported by the legal brief, the patient underwent placement of a optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: dvt, caval thrombosis.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.According to the information received in the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc, and dvt.The following additional information was received per medical records: although the exact implant date is unknown, medical records indicate that the patient was admitted to the hospital with the optease filter implanted and was found to have a gi bleed.When treated conservatively with elevation, the patient regressed and developed phlegmasia with tissue compromise with the need for emergent surgery.The patient was heparinized and underwent a right and left groin exploration with balloon thromboembolectomy of the ivc in the right and left common and external iliac veins and common femoral vein, endothrombectomy of the ivc within the indwelling filter using a possis angiojet, angioplasty of the lvc, as well as patch angioplasty of the left saphenofemoraljunction, bilateral lower extremity anterior and lateral compartment fasciotomies.Via right groin, a transverse venotomy was performed in the saphenous vein and a wire was advanced up into the ivc.Angiograms were performed which confirmed occlusion and a balloon thromboembolectomy of the ivc and left common/external iliac was performed.Attempts were made to perform embolectomy of the indwelling optease filter.This was unsuccessful, with a significant amount of retained clot burden.Endothrombectomy was performed and the occlusion was not resolved.The balloon was upsized and pullback balloon thromboembolectomies of the ivc, common and external iliac veins was completed, and venous flow results improved.A longitudinal incision was made on the anterolateral aspect of both the right and left lower legs and dissection was carried down to the lateral and anterior compartments, where fasciotomies were performed.Angiographic findings demonstrated an occluded lvc, common and external iliac veins.After initial balloon thromboembolectomy there was still noted to be significant amount of clot burden.After balloon thromboembolectomy with a larger balloon, the ivc, common and external iliac arteries were patent with much less clot burden except for within the ivc filter.

Manufacturer Narrative

Additional information: section b4 (event description: according to the information received in the patient profile form (ppf), the patient reports depression and a blood leak which required 4 transfusions.) section h6 (evaluation codes: addition of code 2597- blood loss) complaint conclusion: 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 experienced blood clots, clotting and/or occlusion of the inferior vena cava (ivc) and a deep vein thrombosis (dvt).The patient also reported having experienced phlegmasia with tissue compromise requiring surgical intervention.The patient then underwent angioplasty and thrombectomy within the ivc, left common and external iliac veins and common femoral vein and the sapheno-femoral junction.This was followed by bilateral lower extremity anterior and lateral compartment fasciotomies and further thrombectomy within the filter and to the previously treated veins.This proved to be unsuccessful with a significant amount of retained clot burden.Further thrombectomy did not improve the clot burden within the filter but did improve venous flow.The open groin incisions were subsequently washed out and closed.The patient further reported having experienced bleeding, mental anguish and depression.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 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.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.Blood clots and thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Blood loss is a known potential adverse event associated to the filter device.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.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, mental anguish, fear, 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 brief, the patient underwent placement of a optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: dvt, caval thrombosis.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.According to the information received in the patient profile form (ppf): at some point after the filter implantation, the patient experienced blood clots, clotting and/or occlusion of the inferior vena cava (ivc) and a deep vein thrombosis (dvt).The patient further reported having experienced mental anguish and depression.The following additional information was received per medical records: the indication for the filter placement was not reported.At some point after the filter implantation, the patient experienced blood clots, clotting and/or occlusion of the inferior vena cava (ivc) and a deep vein thrombosis (dvt).The patient also reported having experienced phlegmasia with tissue compromise requiring surgical intervention.The patient then underwent angioplasty and thrombectomy within the ivc, left common and external iliac veins and common femoral vein and the sapheno-femoral junction.This was followed by bilateral lower extremity anterior and lateral compartment fasciotomies and further thrombectomy within the filter and to the previously treated veins.This proved to be unsuccessful with a significant amount of retained clot burden.Further thrombectomy did not improve the clot burden within the filter but did improve venous flow.The open groin incisions were subsequently washed out and closed.According to the information received in the amended patient profile form (ppf), the patient reports depression and a blood leak which required 4 transfusions.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9298081
• MDR Text Key: 167137229
• Report Number: 1016427-2019-03530
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR