MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466F220A

Device Problems Occlusion Within Device (1423); Therapy Delivered to Incorrect Body Area (1508); Retraction Problem (1536)

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

Event Date 10/27/2015

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.  as reported through the legal department via a legal brief, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the ivc filter, and had to be removed, it was replaced with a different filter.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.No additional information is available.  the product was not returned for inspection.Manufacturing records (dhr) could not be performed as the product catalog and lot number were not available.  the cordis optease® vena cava filter (filter) is designed for the prevention of recurrent pulmonary embolism via placement in the inferior vena cava (ivc).The self-centering optease filter is laser cut from nickel titanium alloy (nitinol) tubing.The proximal and distal baskets of the optease filter, which consist of struts in a six diamond-shape configuration, are designed for optimal clot capture.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 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 occlusion of the ivc filter do not represent product malfunctions.Rather, patient and pharmacological factors may have contributed to these events.As per the instructions for use (ifu), the optease filter may be retrieved according to the instructions supplied in the section labeled: optional procedure for filter retrieval.Retrieval of the filter should not be attempted if thrombus is present in the filter and/or caudal to the filter.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.  please note that this is the initial/final report for this product.

Event Description

As reported through the legal department via a legal brief, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the ivc filter, and had to be removed, it was replaced with a different filter.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.No additional information is available.

Manufacturer Narrative

The following additional information received per the medical records indicate that the patient underwent placement of the ivc filter because of their history of having a left lower extremity deep venous thrombosis with recent subdural hematoma with contraindications to anticoagulation therapy.The ivc filter was successfully deployed below the level of the renal veins via the right brachial vein.A post procedure venogram showed good position of the filter in the ivc below the level of the renal veins.The patient tolerated the procedure well.The following day post implantation of the ivc filter, the filter was found to have the hook oriented superiorly and was removed via right internal jugular vein.During the ivc filter removal, an attempt was made to advance the sheath over the filter.The filter buckled somewhat but there was difficulty in advancing into the sheath.Therefore, the wire was replaced, and the sheath was exchanged.Again, the filter tip was snared at the retrieval hook and this time the filter was successfully collapsed and housed in the sheath.Upon successfully removal, the filter was examined and noted to contain some clot.Another ivc filter was then deployed below the lowest renal vein.The patient tolerated the procedure well.According to the information received in the patient profile from (ppf), approximately one day post implantation of ivc filter, the filter was removed percutaneously.Approximately on or about six years and nine months post implantation of the ivc filter the patient reports the filter was implanted upside down.The patient also reports that the extent of any possible device failure has not been fully documented by the patient¿s treating medical provider.It was reported that a patient underwent placement of an optease inferior vena cava (ivc) filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the ivc filter, and had to be removed and replaced with a different filter.According to the information received in the patient profile from (ppf), the filter was removed and replaced with a different filter the day after the initial implant.The indication for the filter implant was a recent intracranial hemorrhage status post evacuation of a subdural hematoma in a patient with a history of left lower extremity deep vein thrombosis (dvt) and a contraindication to anticoagulants given the recent history of bleeding.The optease filter was placed via the right brachial vein and was then successfully deployed.A post procedure venogram showed good position of the filter in the ivc below the level of the renal veins.The patient tolerated the procedure well.The following day post implantation of the ivc filter, the filter was found to have the hook oriented superiorly and was removed via the right internal jugular vein.During the ivc filter removal, an attempt was made to advance the sheath over the filter.The filter buckled somewhat but there was difficulty in advancing into the sheath.Therefore, the wire was replaced, and the sheath was exchanged.Again, the filter tip was snared at the retrieval hook and this time the filter was successfully collapsed and housed in the sheath.Upon successfully removal, the filter was examined and noted to contain some clot.Another ivc filter was then deployed below the lowest renal vein.The patient tolerated the procedure well.The medical records noted that the procedure should not be charged to the patient.There is currently no additional information available for review.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.Blood clots, clotting and thrombosis within the filter do not represent a device malfunction.Clinical factors that may have influenced these events include patient, pharmacological and lesion characteristics.The report of the filter hook oriented superiorly could not be confirmed or further clarified without procedural implant images available for review.Procedural factors may have contributed to the orientation of the filter hook.Given the limited information currently available for review, 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: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tipperary ; EI
• MDR Report Key: 6721190
• MDR Text Key: 80287158
• Report Number: 1016427-2017-00463
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466F220A
• Device Lot Number: R0908158
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/21/2017
• Date Manufacturer Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 57 YR