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

Model Number 466FXXXX

Device Problems Occlusion Within Device (1423); Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Thrombosis (2100)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

As reported by the legal team, plaintiff underwent placement of defendants' optease vena cava filter on or about (b)(6) 2010.The filter subsequently malfunctioned and caused injury and damages to plaintiff, including, but not limited to, blood clots, clotting and occlusion of the lvc filter, and recurrent deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  the device was not returned for analysis.   a device history record (dhr) review could not be conducted as the sterile lot number was not provided.  without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.Neither blood clots, clotting nor thrombus within the vessel (or in the filter) represent a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.The product¿s instructions for use (ifu) indicate that filter obstruction and thrombus formation are potential complications of filter implantation.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 by the legal team, plaintiff underwent placement of defendants' optease vena cava filter on or about (b)(6) 2010.The filter subsequently malfunctioned and caused injury and damages to plaintiff, including, but not limited to, blood clots, clotting and occlusion of the lvc filter, and recurrent deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, plaintiff  suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

The following additional information received per the patient profile from (ppf) indicates that the patient is suffering from anxiety.According to medical records, the indications for the procedure were recurrent pulmonary embolism (pe) and high risk for recurrent pe.The filter was successfully deployed in the ivc inferiorly to the renal veins during the index procedure.The patient returned to recovery in good condition.Corrected data: initial reporter name and address.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 an optease inferior vena cava (ivc) filter.Per medical records, the indications for the procedure were recurrent pulmonary embolism (pe) and high risk for recurrent pe.The filter was successfully deployed in the ivc inferiorly to the renal veins during the index procedure.The patient returned to recovery in good condition.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 (lvc) filter, and recurrent deep vein thrombosis (dvt).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.The following additional information received per the patient profile from (ppf) indicates that the patient is suffering from anxiety.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.Blood clots and occlusive thrombosis within the filter do not represent a device malfunction.Anxiety 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.

Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava 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 inferior vena cava (lvc) filter, and recurrent deep vein thrombosis (dvt).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.The following additional information received per the patient profile from (ppf) indicates that the patient is suffering from anxiety.According to medical records, the indications for the procedure were recurrent pulmonary embolism (pe) and high risk for recurrent pe.The filter was successfully deployed in the ivc inferiorly to the renal veins during the index procedure.The patient returned to recovery in good condition.According to the discovery form, the patient received the ivc filter for blood clot in the left lung and shortness of breath.Medical conditions and treatments alleged to be attributable to the implanted ivc filter include ectasia in the distal ivc of uncertain significance.The patient further reports that the filter has "turned" and caused damage and is worried that the filter will continue to move and cause additional damage or even death.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient appears to have presented with shortness of breath and pulmonary embolism (pe).The indication for the filter placement was reported to be a high risk for further pe.The filter was implanted via the right femoral vein and successfully deployed in an infrarenal location.Approximately five years and ten months after the filter implantation, the patient became aware that the filter had ¿turned¿.The filter is also reported to have been associated with blood clots, clotting and/or occlusion of the filter and recurrent deep vein thrombosis (dvt).The patient also reported having experienced left lung and ectasia in the distal inferior vena cava (ivc) of unknown significance.The patient further reported having experienced anxiety, mental anguish and worry associated with the filter.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pe via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.Aneurysm, blood clots and thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in 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; miami FL ; EI
• MDR Report Key: 6518107
• MDR Text Key: 73605597
• Report Number: 1016427-2017-00289
• 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
• Report Date: 09/13/2019

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 Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/30/2017
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: 12/05/2017; 01/09/2018; 08/29/2019
• Supplement Dates FDA Received: 01/03/2018; 01/23/2018; 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 46 YR