MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN OPTEASE RETREIVABLE VENA CAVA FILTER; THROMBECTOMY SYSTEM

Model Number N/A

Device Problems Fracture (1260); Occlusion Within Device (1423)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); No Consequences Or Impact To Patient (2199)

Event Date 09/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available.Patient demographics including medical history were not provided.If obtained, a follow up report will be submitted within 30 days upon receipt.As reported, the patient underwent placement of an optease vena cava which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter fractures and occlusion of the ivc.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 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 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.Occlusion within the ivc does not represent a device malfunction.An occlusion within the vena cava or lower extremities may impede perfusion and cause venous insufficiency leading to possible swelling and pain of the lower extremities.Without procedural films available for review, the reported fracture could not be confirmed and the exact cause could not be determined.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.However, 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 which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter fractures and occlusion of the ivc.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

The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the alleged failures three years and eleven months post implantation.The patient also reports that the filter is unable to be retrieved, however, there have been no attempts made to remove the filter.According to the information received in the medical records, the patient had a history of unprovoked right lower extremity deep vein thrombosis (dvt), hypertension, depression and chronic back pain due to degenerative disc disease.The filter was placed due to the patient¿s history of dvt and the patient being unable to tolerate coumadin due to hemarthrosis.The filter was placed at a lower level than usual due to the slight lower location of the patient¿s kidneys without any reported complications.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 was placed due to the patient¿s history of deep vein thrombosis (dvt)and the patient being unable to tolerate coumadin due to hemarthrosis.The filter was placed at a lower level than usual due to the slight lower location of the patient¿s kidneys without any reported complications.According to the information received in the medical records, the patient had a history of unprovoked right lower extremity dvt, hypertension, depression and chronic back pain due to degenerative disc disease.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter fractures and occlusion of the inferior vena cava (ivc).The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the alleged failures three years and eleven months post implantation.The patient also reports that the filter is unable to be retrieved, however, there have been no attempts made to remove the filter.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.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.

Manufacturer Narrative

The catalog number is unknown.If received, it will be provided.Complaint conclusion: as reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter was placed due to the patient¿s history of dvt and the patient being unable to tolerate coumadin due to hemarthrosis.The filter was placed at a lower level than usual due to the slight lower location of the patient¿s kidneys without any reported complications.According to the information received in the medical records, the patient had a history of unprovoked right lower extremity deep vein thrombosis (dvt), hypertension, depression and chronic back pain due to degenerative disc disease.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter fractures and occlusion of the inferior vena cava (ivc).The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the alleged failures three years and eleven months post implantation.The patient also reports that the filter is unable to be retrieved, however, there have been no attempts made to remove the filter.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.Additional information: the following is a review of the images provided: image 1: angiographic image of pelvic region.Outline of an ivc filter noted, possible optease model due to hook noted on tip pointing towards the pelvic region.The left side of the filter appears as if the strut may bend inward.No apparent clinical conclusion of the cause.Unsure if due to possible fracture or patient anatomy.Image 2: angiographic image of adnominal region.Outline of an ivc filter noted, possible optease model due to hook noted on tip pointing towards the pelvic region.The left side of the filter appears as if the strut may bend inward.No apparent clinical conclusion of the cause.Unsure if due to possible fracture or patient anatomy.Image 3: lat lumbar spine image: opaque outline of an ivc filter noted possible optease model due to hook noted on tip pointing towards the pelvic region.Image quality poor.Unable to determine if fractured struts are present or if patient anatomy cause of possible shape of ivc filter.Image 4: lumbar spine lat image: opaque outline of an ivc filter noted possible optease model due to hook noted on tip pointing towards the pelvic region.Image quality poor.Unable to determine if fractured struts are present or if patient anatomy cause of possible shape of ivc filter.Image 5: lumbar spine lat image: opaque outline of an ivc filter noted possible optease model due to hook noted on tip pointing towards the pelvic region.Image quality poor.Unable to determine if fractured struts are present or if patient anatomy cause of possible shape of ivc filter.Image 6: lumbar l-5/s-1 : opaque outline of an ivc filter noted possible optease model due to hook noted on tip pointing towards the pelvic region.Image quality poor.One strut may appear to have possible fracture.

Event Description

As reported by 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, filter fractures and occlusion of the inferior vena cava (ivc).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 form (ppf) indicates that the patient became aware of the alleged failures three years and eleven months post implantation.The patient also reports that the filter is unable to be retrieved, however, there have been no attempts made to remove the filter.According to the information received in the medical records, the patient had a history of unprovoked right lower extremity deep vein thrombosis (dvt), hypertension, depression and chronic back pain due to degenerative disc disease.The filter was placed due to the patient¿s history of dvt and the patient being unable to tolerate coumadin due to hemarthrosis.The filter was placed at a lower level than usual due to the slight lower location of the patient¿s kidneys without any reported complications.Additional information: the following is a review of the images provided: image 1: angiographic image of pelvic region.Outline of an ivc filter noted, possible optease model due to hook noted on tip pointing towards the pelvic region.The left side of the filter appears as if the strut may bend inward.No apparent clinical conclusion of the cause.Unsure if due to possible fracture or patient anatomy.This image 2: angiographic image of adnominal region.Outline of an ivc filter noted, possible optease model due to hook noted on tip pointing towards the pelvic region.The left side of the filter appears as if the strut may bend inward.No apparent clinical conclusion of the cause.Unsure if due to possible fracture or patient anatomy.Image 3: lat lumbar spine image: opaque outline of an ivc filter noted possible optease model due to hook noted on tip pointing towards the pelvic region.Image quality poor.Unable to determine if fractured struts are present or if patient anatomy cause of possible shape of ivc filter.Image 4: lumbar spine lat image: opaque outline of an ivc filter noted possible optease model due to hook noted on tip pointing towards the pelvic region.Image quality poor.Unable to determine if fractured struts are present or if patient anatomy cause of possible shape of ivc filter.Image 5: lumbar spine lat image: opaque outline of an ivc filter noted possible optease model due to hook noted on tip pointing towards the pelvic region.Image quality poor.Unable to determine if fractured struts are present or if patient anatomy cause of possible shape of ivc filter.Image 6: lumbar l-5/s-1 : opaque outline of an ivc filter noted possible optease model due to hook noted on tip pointing towards the pelvic region.Image quality poor.One strut may appear to have possible fracture.

Event Description

As reported by 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, filter fractures and occlusion of the inferior vena cava (ivc).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 form (ppf) indicates that the patient became aware of the alleged failures three years and eleven months post implantation.The patient also reports that the filter is unable to be retrieved, however, there have been no attempts made to remove the filter.According to the information received in the medical records, the patient had a history of unprovoked right lower extremity deep vein thrombosis (dvt), hypertension, depression and chronic back pain due to degenerative disc disease.The filter was placed due to the patient¿s history of dvt and the patient being unable to tolerate coumadin due to hemarthrosis.The filter was placed at a lower level than usual due to the slight lower location of the patient¿s kidneys without any reported complications.Additional information: the following is a review of the images provided: image 1: angiographic image of pelvic region.Outline of an ivc filter noted, possible optease model due to hook noted on tip pointing towards the pelvic region.The left side of the filter appears as if the strut may bend inward.No apparent clinical conclusion of the cause.Unsure if due to possible fracture or patient anatomy.Image 2: angiographic image of adnominal region.Outline of an ivc filter noted, possible optease model due to hook noted on tip pointing towards the pelvic region.The left side of the filter appears as if the strut may bend inward.No apparent clinical conclusion of the cause.Unsure if due to possible fracture or patient anatomy.Image 3: lat lumbar spine image: opaque outline of an ivc filter noted possible optease model due to hook noted on tip pointing towards the pelvic region.Image quality poor.Unable to determine if fractured struts are present or if patient anatomy cause of possible shape of ivc filter.Image 4: lumbar spine lat image: opaque outline of an ivc filter noted possible optease model due to hook noted on tip pointing towards the pelvic region.Image quality poor.Unable to determine if fractured struts are present or if patient anatomy cause of possible shape of ivc filter.Image 5: lumbar spine lat image: opaque outline of an ivc filter noted possible optease model due to hook noted on tip pointing towards the pelvic region.Image quality poor.Unable to determine if fractured struts are present or if patient anatomy cause of possible shape of ivc filter.Image 6: lumbar l-5/s-1 : opaque outline of an ivc filter noted possible optease model due to hook noted on tip pointing towards the pelvic region.Image quality poor.One strut may appear to have possible fracture.According to the discovery form, the patient received the ivc filter for deep vein thrombosis (dvt).Medical conditions and treatments alleged to be attributable to the implanted ivc filter include emotional distress; fracture of filter leg and elevated risk of future injury due to fractured leg; medical advice not to remove the filter due to high risk of retrieval attempt.

Manufacturer Narrative

As reported, the patient had placement of an optease inferior vena cava (ivc) filter.Per the medical records, history includes unprovoked right lower extremity deep vein thrombosis (dvt), hypertension, depression and chronic back pain due to degenerative disc disease.The filter was placed due to history of dvt and inability to tolerate coumadin due to hemarthrosis.The filter was placed at a lower level than usual due to the slight lower location of the patient¿s kidneys without any reported complications.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter fractures and occlusion of the ivc.Per the patient profile form (ppf), the patient reports that the filter is fractured and unable to be retrieved, however, there have been no attempts made to remove the filter.The patient further reports emotional distress.X-ray images reveal the outline of an ivc filter noted, possible optease model due to hook noted on tip pointing towards the pelvic region.The left side of the filter appears as if the strut may bend inward or possibly be fractured.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 predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.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.Blood clots and occlusive thrombosis within the filter and vasculature 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.Should additional information become available, the file will be updated accordingly.

• Brand Name: UNKNOWN OPTEASE RETREIVABLE VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEM
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• MDR Report Key: 7289764
• MDR Text Key: 100709663
• Report Number: 1016427-2018-01211
• 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: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• 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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/26/2018
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 64 YR