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

Model Number N/A

Device Problems Therapy Delivered to Incorrect Body Area (1508); Difficult to Remove (1528); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

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.(b)(4).It was reported that a patient underwent placement of an optease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt, embedment into the ivc wall, two failed retrieval attempts, and underwent complex ivc filter retrieval of embedded and inverted filter.¿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.¿ 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 and thrombosis within the filter do not represent a device malfunction.Without the procedural films made available for review, the reported filter tilt, inaccurate placement and retrieval difficulty could not be confirmed.The timing and mechanism of the tilt has not been reported at this time.A clinical conclusion could not be determined as to the cause of the event.The reported retrieval difficulty could not be confirmed and the exact cause could not be determined.It is unknown how long the filter was in situ before attempts at removal were performed.Retrieval of the optease vena cava filter is indicated up to 14 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.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or malfunction of 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.

Event Description

As reported in the legal brief, the patient underwent placement of an optease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt, embedment into the ivc wall, two failed retrieval attempts, and underwent complex ivc filter retrieval of embedded and inverted filter.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.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of stent implantation, extensive deep vein thrombosis throughout the caudal inferior vena cava.A groin approach was precluded because of the substantial thrombus in both the right cia and caudal ivc.The filter was deployed in a good position and the patient tolerated the procedure well.Two months after the index procedure an unsuccessful attempt was made to retrieve the filter.A month later, a second unsuccessful attempt was made to retrieve the filter.According to the patient profile form (ppf) the patient experienced pain (leg, groin, knee, chest, migraine and neck) that lead to the patient presenting at an emergency room.The patient also has bumpy scars from the procedures.The patient had also experienced anxiety, which included nightmares, difficulty sleeping, depression, anger/irritability, embarrassment and panic attacks.Additional information is pending and will be submitted within 30 days of receipt.

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 inferior vena cava (ivc) filter.The information provided indicated that the filter malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt, embedded into the ivc wall, two failed retrieval attempts, and underwent complex ivc filter retrieval of embedded and inverted filter.The patient is also reported to have experienced pain (leg, groin, knee, chest, migraine and neck) and has bumpy scars from surgical procedures.The patient has also experienced anxiety, which included nightmares, difficulty sleeping, depression, anger/irritability, embarrassment and panic attacks.The patient¿s medical history is significant for may-thurner syndrome.The indication for the filter implant extensive deep vein thrombosis (dvt) throughout the caudal ivc, the left iliac, common femoral and superficial femoral veins.Additional dvt in the left renal vein and right common iliac vein.It was decided to implant an ivc filter prior to attempting left leg and pelvic thrombolysis.Femoral approach for the device placement was precluded by the substantial thrombus in both the right common iliac vein and the caudal ivc.The filter was placed via the right jugular vein, ivc angiogram confirmed eccentric mobile thrombosis in the caudal ibc, complete thrombosis of the left iliac vein and partial thrombosis of the right common iliac vein.The filter was deployed in the usual fashion, post deployment angiogram showed good position of the filter without any extravasation.The patient tolerated the procedure well without any immediate complications.The procedural notes for any thrombolysis that was performed have not been provided, however it is noted that thrombolysis was performed as well as pelvic stents implanted.Approximately two months post implant a percutaneous attempt was made to retrieve the filter via the right internal jugular vein.Imaging showed no evidence of trapped clot within the filter, it was noted though that the filter was slightly tilted, and eccentric filling defect was noted against the ivc wall.The previously placed stents were noted to be patent.Prolonged attempts at snaring the upper hook of the filter were unsuccessful.Access was changed to the right common femoral vein and a snare was positioned over the caudal aspect of the filter in an effort to straighten the tilt, this too was unsuccessful.The procedure was then finalized.Review of the venograms and previous computerized tomography (ct) scans indicated that a clot embedded in the wall of the lateral left lateral wall of the ivc was causing the filter to tilt and making retrieval difficult.The decision was made to keep the patient on anticoagulation and repeat a ct scan in six weeks.Approximately a month and a half later a secondary attempt was made to remove the filter via the right internal jugular vein.After using multiple snares unsuccessfully, the procedure was ended.A venogram performed at the time showed no changes since the last images were taken.Approximately seven years post implant the patient underwent successful complex removal of the filter via the right internal jugular vein.The notes from the procedure indicate, successful retrieval of chronically embedded and inverted optease filter, removal of focal scar tissue from the ivc and successful venoplasty of the infrarenal ivc.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.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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.Without images or procedural films for review the reported tilt, retrieval difficulty and filter inverted could not be confirmed.Clinical factors that may have influenced any reported events include underlying patient co-morbidities, pharmacological and lesion characteristics.Additionally, the report of the filter being inverted was not noted in the two initial attempts to remove the filter.Anxiety, pain and scars do not represent a device malfunction and may be related to underlying patient specific issues.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: THROMBECTOMY SYSTEMS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7039961
• MDR Text Key: 92298752
• Report Number: 1016427-2017-00746
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• 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: 466F220B
• Device Lot Number: R0607305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/01/2017
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2007
• 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: 42 YR