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); Failure to Align (2522); Unintended Movement (3026)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

The product remains implanted and is thus not available for analysis. a review of the manufacturing records could not be conducted without a lot number.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.

Event Description

As reported in the legal file, (b)(6) vs.Cordis, an unspecified period of time after an optease filter was implanted, the filter migrated, there were blood clots, clotting and occlusion of the ivc and filter, and the filter was unable to be removed. the patient has reportedly suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.

Manufacturer Narrative

As reported in the legal file, in an unspecified period of time after an optease filter was implanted, the filter migrated, there were blood clots, clotting and occlusion of the ivc and filter, and the filter was unable to be removed.The patient has reportedly suffered and will continue to suffer significant medical expenses, 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 in the device or inferior vena cava does not represent a device malfunction.Without procedural films for review, the reported migration and retrieval difficulty could not be confirmed and the exact cause could not be determined.The dates of implantation and attempted retrieval are unknown at this time.Retrieval of the optease vena cava filter is indicated up to 23 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Given the limited information available at this time, the timing and mechanism of the filter migration are unknown.Clinical factors 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.

Manufacturer Narrative

As reported in the legal file, in an unspecified period of time after an optease filter was implanted, the filter tilted and the patient experienced swelling and pain.The patient has reportedly suffered and will continue to suffer significant medical expenses, 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 in the device or inferior vena cava does not represent a device malfunction.Without procedural films for review, the reported tilt could not be confirmed and the exact cause could not be determined.The dates of implantation and attempted retrieval are unknown at this time.Retrieval of the optease vena cava filter is indicated up to 23 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Given the limited information available at this time, the timing and mechanism of the filter tilt are unknown.Clinical factors contributing to the swelling and pain could not be determined.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.

Manufacturer Narrative

He following additional information received per the medical records indicate that two years and ten months post implantation, the patient underwent a dopler examination of the right lower extremity.It was noted that the patient had mild atherosclerotic plaque within the common femoral, superficial femoral, popliteal, posterior tibial and dorsalis arteries.The patient also had significant stenosis of the anterior tibial artery.According to the information received in the patient profile from (ppf), patient underwent the unsuccessful attempt to remove the filter four months and twenty-four days post implantation.The patient also reports to have poor blood circulation in the leg and to be suffering from mental anguish.(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, 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, tilt, embedment to the wall of the inferior vena cava (ivc), and failed retrieval attempt leading to further injury, including, but not limited to, pain and swelling.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The following additional information received per the medical records indicate that two years and ten months post implantation, the patient underwent a doppler examination of the right lower extremity.It was noted that the patient had mild atherosclerotic plaque within the common femoral, superficial femoral, popliteal, posterior tibial and dorsalis arteries.The patient also had significant stenosis of the anterior tibial artery.According to the information received in the patient profile from (ppf), patient underwent the unsuccessful attempt to remove the filter four months and twenty-four days post implantation.The patient also reports to have poor blood circulation in the leg and to be suffering from mental anguish.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) 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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.It was also reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Pain, swelling and anxiety do not represent a device malfunction and may be related to underlying patient related issues.Poor peripheral circulation 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.

• Brand Name: OPTEASE VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEMS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• MDR Report Key: 6400707
• MDR Text Key: 69809904
• Report Number: 1016427-2017-00233
• 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: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466FXXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/16/2017
• Date Manufacturer Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 53 YR