MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER; THROMBECTOMY SYSTEMS

Model Number N/A

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

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Edema (1820); Hemorrhage/Bleeding (1888); Occlusion (1984); Thrombosis (2100); No Code Available (3191)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is an optease vena cava 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 moody vs.Cordis, an unspecified period of time after placement of an optease vena cava filter, the device reportedly malfunctioned and caused injury and damaged, but limited to blood clots, clotting and occlusion of the ivc.  as a direct and proximate result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages, and required extensive medical care and treatment.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.Blot clots, clotting and occlusion of the ivc does not represent a device malfunction.The reported events 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)(4) vs.Cordis, an unspecified period of time after placement of an optease vena cava filter, the device reportedly malfunctioned and caused injury and damaged, but limited to blood clots, clotting and occlusion of the ivc.  as a direct and proximate result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages, and required extensive medical care and treatment.

Manufacturer Narrative

The following additional information received per the medical records indicate that the patient underwent placement of the ivc filter due to having a history of left leg deep vein thrombosis (dvt) and retroperitoneal hemorrhage.The patient also has a history of left hip surgery and coagulopathy.During the placement of the ivc filter via the right common femoral vein, the filter was deployed and positioned halfway between the renal veins and common iliac veins.A completion cavogram demonstrated satisfactory position of the caval filter.The patient tolerated the procedure well without complications.According to the information received in the patient profile from (ppf), sometime post implantation of the ivc filter the patient reports to have experienced bleeding, and restless legs.It is also reported that the patient suffers from severe bilateral leg edema which represents an inferior vena cava syndrome due to the filter.Approximately on or about nine days post implantation of the filter the patient underwent a computed tomography (ct) pulmonary angiogram in which it was noted that the patient had a saddle embolus at the bifurcation of the right main pulmonary artery.A ct scan of the abdomen also showed the filter was clotted from a point just above the filter to well below the filter.The patient also reported that the device is unable to be retrieved.According to the ppf, the patient states that the removal of the ivc filter would be extremely high risk and was not recommended for the patient now or at any time in the future.No actual attempts to retrieve the filter are noted.The patient will remain on anticoagulation.The patient states to now suffer from severe bilateral lymphedema for which patient is undergoing treatment including wrapping and compression.In addition, the patient reports reduced lung function, shortness of breath, chronic leg pain, mental anguish, and emotional distress.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, the patient underwent placement of the optease inferior vena cava (ivc) filter.Per the medical records, the patient underwent placement of the ivc filter due to having a history of left leg deep vein thrombosis (dvt) and retroperitoneal hemorrhage.The patient also has a history of left hip surgery and coagulopathy.During the placement of the ivc filter via the right common femoral vein, the filter was deployed below the renal veins.A completion cavogram demonstrated good position of the filter.The patient tolerated the procedure well without complications.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc).Per the patient profile from (ppf), sometime post implantation of the ivc filter the patient reports to have experienced bleeding, and restless legs.It is also reported that the patient suffers from severe bilateral leg edema which represents an inferior vena cava syndrome due to the filter.Approximately on or about nine days post implantation of the filter the patient underwent a ct pulmonary angiogram in which a saddle embolus at the bifurcation of the right main pulmonary artery was noted.A ct scan of the abdomen showed there was clot from above to below the filter.The patient also reported that the device is unable to be retrieved.The patient reports severe bilateral lymphedema being treated with wrapping and compression.In addition, the patient reports reduced lung function, shortness of breath, chronic leg pain, mental anguish, and emotional distress.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Blood clots, clotting, ivc syndrome, bleeding, pulmonary embolus and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, leg pain, lung function decrease, lymphedema and restless leg syndrome do 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.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.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: THROMBECTOMY SYSTEMS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014
• MDR Report Key: 6449372
• MDR Text Key: 71391383
• Report Number: 1016427-2017-00248
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 466F220A
• Device Lot Number: R1108432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/07/2017
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR