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

Catalog Number 466F220A

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 03/01/2012

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to deep vein thrombosis, pulmonary embolism, leg swelling and pain.The filter was fractured.The patient has also undergone a thrombectomy and a failed removal procedure.The filter remains implanted; thus, unavailable for analysis.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.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, 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.Blood clots, dvt, post procedural pulmonary embolism and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Swelling of the legs and pain do 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.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 an 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 deep vein thrombosis, pulmonary embolism, leg swelling and pain.The filter was fractured.The patient has also undergone a thrombectomy and a failed removal procedure.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

Event: as reported, the patient had placement of an optease inferior vena cava (ivc) filter.Per the medical records, history includes pulmonary embolism with extensive left leg deep vein thrombosis.The patient also has a history of right leg deep vein thrombosis.The medical records noted that the filter was retrievable, but the filter was placed with the intent for it to remain permanently.The filter was placed in the infrarenal area of the inferior vena cava.The patient tolerated the procedure well without an acute complication.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to deep vein thrombosis, pulmonary embolism, leg swelling and pain.The filter was fractured.The patient has also undergone a thrombectomy and a failed removal procedure.Per the patient profile form (ppf), the patient reports perforation of filter strut(s) outside the inferior vena cava, filter embedded in wall of the inferior vena cava, blood clots, clotting, and/or occlusion of the inferior vena cava, the device was fractured and the fractured struts have been removed from the patient's body, leg pain, daily leg swelling, permanent leg damage, leg trauma, stomach pain, pain, mental trauma and mental anguish.One year after the index procedure, there was an unsuccessful attempt to remove the filter.The form states that the device was removed and also states that device was not removed.It is unclear if the device explanted.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 instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.It was 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.Ivc 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, leg injury, swelling and pain do 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.Should additional information become available, the file will be updated accordingly.

Manufacturer Narrative

Corrected data section d6: per medical records, the implant date is june 15, 2011.After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b7, d1, d4, d6, d11, g3, g4, g7, h1, h2 and h4.Section b5: additional information received per the medical records indicate that the patient has a history of pulmonary embolism with extensive left leg deep vein thrombosis.The patient also has a history of right leg deep vein thrombosis.The medical records noted that the filter was retrievable, but the filter was placed with the intent for it to remain permanently.  the filter was deployed via the right internal jugular.It was placed in the infrarenal area of the inferior vena cava.The patient tolerated the procedure well without an acute complications.  additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the inferior vena cava, filter embedded in wall of the inferior vena cava, blood clots, clotting, and/or occlusion of the inferior vena cava, leg pain, daily leg swelling, permanent leg damage, leg trauma, stomach pain, pain, mental trauma and mental anguish.The patient became aware of the reported events (deep vein thrombosis and pulmonary embolism) approximately nine months after the index procedure one year after the index procedure, there was an unsuccessful attempt to remove the filter.The ppf states that the device was fractured and the fractured struts have been removed from the patient's body.The form states that the device was removed and it also states that device was not removed.The form states that the removal attempt was unsuccessful and the form also states that the currently location of the device is with a custodian.It is unclear if the device explanted.Additional information is pending and will be submitted within 30 days of receipt.

• 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: 7943522
• MDR Text Key: 123050142
• Report Number: 1016427-2018-01919
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• 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: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Catalogue Number: 466F220A
• Device Lot Number: 15095407
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2019
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETERS; UNKNOWN GUIDE WIRE; UNKNOWN PIGTAIL CATHETER
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 52 YR