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

Model Number N/A

Device Problems Occlusion Within Device (1423); Difficult to Remove (1528); Unintended Movement (3026)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 03/07/2017

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, a patient underwent placement of an optease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including, blood clots, clotting and occlusion of ivc and iliac vein, migration of ivc filter, requiring two stents around the filter for proper blood flow.As a direct and proximate result of these malfunctions, the patient reportedly suffered life threatening injuries and damages, and required extensive 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.Thrombosis and/or clots do not represent a device malfunction.Without images or procedural films for review, the reported filter migration could not be confirmed and the exact cause could not be determined.Giving the limited information available at this time, clinical factor contributing to the migration could not be determined.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.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, the patient underwent placement of an optease vena cava filter which reportedly subsequently, malfunctioned and caused injury and damages to the patient, including, blood clots, clotting and occlusion of ivc and iliac vein, migration of ivc filter, requiring two stents around the filter for proper blood flow.As a direct and proximate result of these malfunctions, the patient reportedly suffered life threatening injuries and damages, and required extensive medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.It was reported that a patient underwent placement of an optease vena cava filter.The information indicated that the device subsequently malfunctioned and caused injury and damages to the patient, including, blood clots, clotting and occlusion of ivc and iliac vein, migration of ivc filter, requiring two stents around the filter for proper blood flow.As a direct and proximate result of these malfunctions, the patient reportedly suffered life threatening injuries and damages, and required extensive medical expenses, and pain and suffering, and other damages.The following additional information received per the patient profile form (ppf) indicates the filter was placed due to lower extremity venous thrombosis.The ppf also indicates that the patient became aware approximately two weeks after the implant that the device cannot be retrieved although there have been not known documented attempts at retrieval.The patient is reported to experience anxiety, pain, varicose veins and lymphedema related to the device.There is currently no additional information available.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 and thrombosis within the filter do not represent a device malfunction.Without procedural films and post implant imaging available for review, the reported filter migration, retrieval difficulty, clotting, blood clots and vena caval occlusion could not be confirmed and the exact cause could not be determined.The instructions for use (ifu) states that migration is a potential complication associated with vena cava filters.With the limited information provided it is not possible to establish a relationship between the reported filter migration.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.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in swelling of the affected extremity, resulting in discomfort associated with the edema.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information available for review, a relation between the device and the event(s) could not be determined.Pain does not represent a device malfunction.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.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days of this report.

• Brand Name: OPTEASE VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEMS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL 33152
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6447414
• MDR Text Key: 71323023
• Report Number: 1016427-2017-00245
• 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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 466F230AJ
• Device Lot Number: 17205370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/07/2017
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/30/2017
• Supplement Dates Manufacturer Received: 12/07/2017; 01/25/2018
• Supplement Dates FDA Received: 01/07/2018; 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 62 YR