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

Catalog Number 466F220A

Device Problem Failure to Align (2522)

Patient Problems Coagulation Disorder (1779); Perforation (2001); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Bowel Perforation (2668)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.It was reported that a patient underwent placement of an optease vena cava filter.The report indicated that the filter subsequently malfunctioned and caused tilting of the filter and perforation.The indication for the filter implant has not been provided and there is currently no additional information available for review.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 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.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.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.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 by the legal brief, the patient underwent placement of a optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting of the filter and perforation.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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b6, b7, d1, d4, d11, g3, g4, g7, h1, h2, h4 and h6.Section b5: additional information received per the medical records indicate that the patient has a history of deep vein thrombosis and pulmonary embolism.The filter was deployed via the patient's right internal jugular vein.It was placed at the inferior margin of the l1 vertebral body.  additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the inferior vena cava (ivc), perforation of filter strut(s) into organs and tilting of the filter.The patient became aware of the reported events approximately seven years and seven months after the index procedure.The patient continues to experience anxiety, pain and suffering due to perforation of the filter 4-5 mm beyond the wall of the ivc and the perforation of the small bowel/ duodenum. a computed tomography (ct) approximately seven years and seven months after the index procedure revealed that the filter had a number of struts extending 4-5 mm beyond the lumen.Cholelithiasis was also seen.As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of deep vein thrombosis (dvt) and pulmonary embolism (pe) with non-compliance with anticoagulation therapy.The indication for the filter placement was reported to be a new dvt.The filter was implanted via the right internal jugular vein and placed at the inferior margin of the l1 vertebral body.Approximately seven and a half years after the filter implantation, the patient underwent a computerized tomography (ct) scan that revealed that the filter had tilted and was associated with perforation of a number of filter struts approximately 4-5mm outside the wall of the inferior vena cava (ivc) and into the small bowel and/or duodenum.The patient further reported having experienced mental anguish, anxiety, pain and suffering associated with the filter.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 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 and perforation events 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.It is unknown if the tilt contributed to the reported ivc and duodenal perforations.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues 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.

Event Description

As reported by the legal brief, the patient underwent placement of a optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting of the filter and perforation.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, pain and suffering and other damages.Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis and pulmonary embolism.The filter was deployed via the patient's right internal jugular vein.It was placed at the inferior margin of the l1 vertebral body.  additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the inferior vena cava (ivc), perforation of filter strut(s) into organs and tilting of the filter.The patient became aware of the reported events approximately seven years and seven months after the index procedure.The patient continues to experience anxiety, pain and suffering due to perforation of the filter 4-5 mm beyond the wall of the ivc and the perforation of the small bowel/ duodenum.A computed tomography (ct) approximately seven years and seven months after the index procedure revealed that the filter had a number of struts extending 4-5mm beyond the lumen.Cholelithiasis was also seen.According to the information received in the redacted-amended patient profile form (ppf), the patient additionally reports blood clots, clotting and or occlusion of the ivc, becoming aware of these events approximately nine years after the filter implantation.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of deep vein thrombosis (dvt) and pulmonary embolism (pe).The indication for the filter placement was reported to be a new episode of dvt in the setting of non-compliance with anticoagulation therapy.The filter was implanted via the right internal jugular vein and placed at the inferior margin of the l1 vertebral body without complications.Approximately seven years and seven months after the filter implantation, the patient underwent a computerized tomography (ct) scan that revealed that an infrarenal filter with a number of filter strut(s) that had perforated the inferior vena cava (ivc) extending 4-5mm outside its¿ wall.The anterior strut of the filter was noted to be subtly contacting the duodenal diverticulum.The filter was noted to have a mild tilt with its¿ proximal aspect in contact with the anterior wall of the ivc.There was no evidence of ivc stenosis.Approximately nine years after the filter implantation, the patient became aware that the filter was also associated with blood clots, clotting and/or occlusion of the ivc.The patient further reported having experienced anxiety and pain associated with the filter.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 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, ivc and organ perforation events 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.It is unknown if the tilt contributed to the reported perforations.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Stenosis, blood clots, clotting, embolism, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues 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; EI
• MDR Report Key: 9589530
• MDR Text Key: 175032314
• Report Number: 1016427-2020-03734
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 466F220A
• Device Lot Number: 15155787
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6 FRENCH LONG CATHETER; UNKNOWN 0.018 GUIDE WIRE; UNKNOWN 0.018 J WIRE; UNKNOWN 5 FRENCH CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 69 YR
• Patient Weight: 87