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

CORDIS CASHEL OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problems Occlusion Within Device (1423); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Neuropathy (1983); Occlusion (1984); Swelling (2091); Thrombosis (2100); Thrombus (2101)

Event Date 08/20/2014

Event Type Death

Manufacturer Narrative

The product is not available for evaluation and testing. as reported via the legal department, notification of legal action was received.The plaintiff underwent optease retrievable inferior vena cava (ivc) filter implantation which subsequently malfunctioned.The device, inter alia, caused blood clots, clotting and occlusion of ivc filter, and resulting neuropathy in the lower extremities.As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The device remains implanted in the patient and is not available for inspection.Manufacturing records (dhr) could not be reviewed, as the product catalog and lot number are not available.The purpose of a vena cava filter is to catch thrombus (a clot of blood formed within a blood vessel) from the lower extremities as it travels along normal blood flow patterns up towards the heart.Thrombus in the filter or within the vessel does not represent a device malfunction.Thrombosis in the filter is a well-known potential complication and occurs in approximately 3.6 to 11.2% of all patients.As such, it is addressed in the product¿s instructions for use (ifu).Factors that may contribute to thrombus may include patient factors, pharmacological and lesion characteristics.Peripheral neuropathy is damage to or disease affecting nerves, which may impair sensation, movement, gland or organ function, or other aspects of health, depending on the type of nerve affected.Common causes of peripheral neuropathy include systemic diseases (such as diabetes or leprosy), vitamin deficiency, medication, antibiotics, traumatic injury, radiation therapy, excessive alcohol consumption, immune system disease, coeliac disease, or viral infection.Based on the limited information available for review, there is no indication of a design or manufacturing related cause for these events.Therefore, no corrective action will be taken at this time.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 through the legal department via (b)(6), the patient had an optease retrievable inferior vena cava (ivc) filter implanted.The filter subsequently malfunctioned and caused injury and damages to the plaintiff including: but not limited to, blood clots, clotting and occlusion of ivc filter, and resulting neuropathy in the lower extremities.As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the 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 form (ppf) indicates that the filter was unable to be retrieved although there have been no documented attempts made to retrieve the filter.The patient also reports to suffer from leg swelling and pain.According to medical records, the patient had a history of deep vein thrombosis (dvt), intracranial hemorrhage, and was unable to anticoagulate.The filter was successfully deployed and the patient tolerated the procedure well.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following have been updated accordingly.As reported, the patient had an optease retrievable inferior vena cava (ivc) filter implanted.The indication for filter implant was a history of deep vein thrombosis (dvt), intracranial hemorrhage, and was unable to anticoagulate.The filter was successfully deployed and the patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient including but not limited to, blood clots, clotting and occlusion of ivc filter, and resulting neuropathy in the lower extremities.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 filter was considered too dangerous to be removed, and there have been no documented attempts made to retrieve the filter.The patient also reports to suffer from leg swelling, pain and filter occlusion.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 the 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.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.Swelling of the legs with resultant peripheral neuropathy and pain to dot represent device malfunctions.These events may be related to underlying patient specific issues.Clinical factors that may have influenced the event include patient co-morbidities, 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

Additional information is pending and will be submitted within 30 days upon receipt.

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 intracerebral hemorrhage while on anticoagulation therapy.As a consequence, further anticoagulation therapy was deemed to be contraindicated.The indication for the filter placement was reported to be the presence of a dvt and thrombosis of the inferior vena cava (ivc) and pelvic veins and to reduce the risk of clot formation during travel.The filter was successfully implanted via the right internal jugular vein and placed in an infrarenal position.The patient is reported to have tolerated the procedure well and without complications.Approximately nine and a half years after the filter implantation, the patient became aware that the filter had tilted with its¿ apex to the left.Diagnostic testing revealed that the filter was associated with blood clots, clotting and occlusion of the filter resulting in peripheral neuropathy of the lower extremities.The filter was not fractured.This testing appears to have been indeterminate as to whether the filter had perforated the wall of the ivc or if it was embedded in the ivc due to the presence of clot.This testing further noted that the ivc occlusion extended from the filter inferiorly into both lower legs.The patient underwent mechanical thrombectomy of the ivc bilateral external and internal iliac veins.The bilateral external iliac veins were stented.The filter was reported to be too distorted to be retrieved and a stent was placed to span the filter and establish continuous venous flow.During thrombolysis, the patient experienced a desaturation event that was possibly associated with pulmonary embolism (pe) from the large clot burden.This desaturation required intubation and mechanical ventilation for a few days; though no pe was identified on angiogram.The patient will require lifelong compressive and anticoagulation therapy.The patient further reported having experienced leg swelling and pain associated with the filter.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 device embedment 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.The predominant concern for embedding within 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.The optease retrievable vena cava filter is indicated for retrieval up to 23 days post-implantation.Following this period of time, and as early as twelve days, there is potential for endothelialization around the filter struts.Usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called dvt.A dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.These events do not represent a malfunction of the device.Recurrent pe is a known potential complication of filter implantation and is listed in the ifu as such.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Blood clots and 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, leg swelling and peripheral neuropathy 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.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.

Manufacturer Narrative

According to additional information received per additional medical records, the indication for intervention was dvt, ivc and pelvic vein thrombosis.Thrombolysis using angiovac device and stent implant was performed.Successful thrombolysis of the ivc, bilateral external and internal iliac veins, bilateral external iliac vein stenting.During the thrombolysis procedure, the patient had a desaturation event that could be related to pulmonary embolism (pe) from large clot burden during the intervention, although no pe was identified on angiogram.

Manufacturer Narrative

It was reported that a patient had an optease retrievable inferior vena cava (ivc) filter implanted.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient including but not limited to, blood clots, clotting and occlusion of ivc filter, and resulting neuropathy in the lower extremities.The information provided also indicated that the filter was unable to be retrieved, there have been no documented attempts made to retrieve the filter.The information provided indicates that the filter was evaluated on two different occasions for removal, however, it is unclear if an actual removal procedure took place.The patient also reports to suffer from leg swelling, pain and filter occlusion.According to medical records, the patient had a history of deep vein thrombosis (dvt), intracranial hemorrhage, and was unable to be anticoagulated.The filter was implanted via the right internal jugular vein and placed with the cephalad cone of the filter immediately below the level of the renal veins, with the filter noted above the level of the venous confluence in good position.The patient is reported to have tolerated the procedure well.Additional information received is a review of imaging, performed by an outside physician, of an inferior venacavogram with intervention.The reviewer noted that the filter was at the level of l2-l3 and the apex of the filter was tilted to the left.Perforation of the filter and embedment was indeterminate due to the presence of clot, however the operators stented across the filter, so an assumption was made that the filter was not able to be removed.No strut fracture was identified.The reviewer noted that ivc occlusion extends from the filter inferiorly to both lower legs.Mechanical thrombectomy was performed on the deep pelvic veins and the ivc.The reviewer notated that the ivc filter was too distorted to remove so an ivc stent was placed spanning the ivc filter to establish continuous flow.The reviewer concluded that the filter is no longer retrievable due to the presence of a bridging stent, the patient will need life-long compressive therapy and some form of anticoagulation.There is currently no additional information available for review.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.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explant, retrieval difficulty, problems after as short a period as 12 days.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt could not be confirmed or further clarified.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with vessel characteristics, specifically asymmetry and tortuousity and technique.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency, resulting in swelling/edema/bulging of the effected extremity(s).Blood clots and thrombosis within the filter do not represent a device malfunction.Occlusion of the ivc filter was reported, however the mechanism of the occlusion was not.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Without the procedural films or post-placement imaging and the limited information provided, the report of blood clots, clotting and occlusion of the inferior vena cava (ivc) and filter could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn.Pain and leg swelling do not represent do not represent a device malfunction and may be related to underlying patient specific issues.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Manufacturer Narrative

It was reported that a patient had an optease retrievable inferior vena cava (ivc) filter implanted.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient including but not limited to, blood clots, clotting and occlusion of ivc filter, and resulting neuropathy in the lower extremities.The information provided also indicated that the filter was unable to be retrieved, there have been no documented attempts made to retrieve the filter.The information provided indicates that the filter was evaluated on two different occasions for removal, however, it is unclear if an actual removal procedure took place.The patient also reports to suffer from leg swelling, pain and filter occlusion.According to medical records, the patient had a history of deep vein thrombosis (dvt), intracranial hemorrhage, and was unable to be anticoagulated.The filter was implanted via the right internal jugular vein and placed with the cephalad cone of the filter immediately below the level of the renal veins, with the filter noted above the level of the venous confluence in good position.The patient is reported to have tolerated the procedure well.Additional information received is a review of imaging, performed by an outside physician, of an inferior venacavogram with intervention.The reviewer noted that the filter was at the level of l2-l3 and the apex of the filter was tilted to the left.Perforation of the filter and embedment was indeterminate due to the presence of clot, however the operators stented across the filter, so an assumption was made that the filter was not able to be removed.No strut fracture was identified.The reviewer noted that ivc occlusion extends from the filter inferiorly to both lower legs.Mechanical thrombectomy was performed on the deep pelvic veins and the ivc.The reviewer notated that the ivc filter was too distorted to remove so an ivc stent was placed spanning the ivc filter to establish continuous flow.The reviewer concluded that the filter is no longer retrievable due to the presence of a bridging stent, the patient will need life-long compressive therapy and some form of anticoagulation.Additional information provided by the patient¿s relatives indicated that the patient is deceased, a cause of death or a relation to the device was not provided.The patient's family reported becoming aware of blood clots, clotting, occlusion of the ivc and device unable to be retrieved, becoming aware of these events about nine years and eight months post implantation.The family additionally reported that the clot formation which occurred due to the ivc filter, and the inability to treat/remove the clot formation, became a stressful mental and physical ordeal.The patient suffered daily from leg swelling and ongoing pain/numbness, and sought treatment, both locally and out of state, for the leg issues/pain but never found any satisfaction or remedy.The product was not returned for analysis.The dhr could not be completed.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.Recurrent pe is a known potential complication of filter implantation and is listed in the ifu as such.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explant, retrieval difficulty, problems after as short a period as 12 days.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt could not be confirmed or further clarified.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with vessel characteristics, specifically asymmetry and tortuosity and technique.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency, resulting in swelling/edema/bulging of the effected extremity(s).Blood clots and thrombosis within the filter do not represent a device malfunction.Occlusion of the ivc filter was reported, however the mechanism of the occlusion was not.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Without the procedural films or post-placement imaging and the limited information provided, the report of blood clots, clotting and occlusion of the inferior vena cava (ivc) and filter could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn.Anxiety, pain and leg swelling do not represent do not represent a device malfunction and may be related to underlying patient specific issues.It was reported that the patient is deceased.As a cause of death was not provided, no clinical determination can be made as to the relationship between the filter and the event.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such 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 had an optease retrievable inferior vena cava (ivc) filter implanted.The filter subsequently malfunctioned and caused injury and damages to the patient including but not limited to, blood clots, clotting and occlusion of ivc filter, and resulting neuropathy in the lower extremities.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 stiffer significant medical expenses, and pain and suffering, and other damages.The following additional information received per the patient profile form (ppf) indicates that the filter was unable to be retrieved although there have been no documented attempts made to retrieve the filter.The patient also reports to suffer from leg swelling, pain and filter occlusion.Per the implant records, the filter was indicated for deep venous thrombosis (dvt) , intracranial hemorrhage and inability to be anticoagulated.Using ultrasound guidance, the right internal jugular vein was accessed and an inferior vena cavagram was performed, revealing a widely patent inferior vena cava with no intraluminal thrombus.The optease ivc filter was deployed below the renal veins.There were no reported complications.According to the information received in the discovery form, the patient had a history of minor blood clots and was on a blood thinner but had an intracerebral bleed and was taken off blood thinners for a short period of time.To reduce risk of a clot forming and traveling to critical areas, an ivc filter was put in place.About nine years and eight months post implantation, the patient presented with leg swelling and pain and was admitted to the hospital with multiple clots, and obstruction around the previously installed ivc filter.Removal of the filter was investigated but thought to be far too risky.Clots were not diminishing, and the legs were swelled to an extreme case resulting in limited mobility and elevated risk of infection.After more than three weeks of leg wraps under hospital care, the patient was transferred to a different facility, and a second examination of the filter was performed, and again it was deemed too risky to remove.An extreme high-risk procedure, to alleviate the clot burden was performed.The patient underwent thrombolysis of occluded inferior vena cava central to, within, and peripheral to the inferior vena cava filter as well as bilateral common iliac and external iliac veins.With successful reduction of clot burden.The clinical history at the time included occlusive ileocaval and partially recanalized bilateral lower extremity dvt markedly symptomatic with phlegmasia and heparin-induced thrombocytopenia with threatened limbs.Additional information received per additional medical records state that the filter was tilted with the apex to the left.Whether the filter tip perforated the wall of the ivc or is embedded in the wall of the ivc is indeterminate due to presence of clot.No strut fracture was confirmed.Ivc occlusion extends from filter inferiorly into both lower legs.Mechanical thrombectomy was performed of the deep pelvic veins and ivc.The filter was too distorted to remove so ivc stent placed spanning the ivc filter to establish continuous venous flow.The filter is no longer retrievable due to presence of a bridging stent and the patient will need life-long compressive therapy and anticoagulation.Per additional medical records, the indication for intervention was dvt, ivc and pelvic vein thrombosis.Thrombolysis using angiovac device and stent implant was performed.Successful thrombolysis of the ivc, bilateral external and internal iliac veins, bilateral external iliac vein stenting.During the thrombolysis procedure, the patient had a desaturation event that could be related to pulmonary embolism (pe) from large clot burden during the intervention, although no pe was identified on angiogram.According to the information received in the redacted-amended patient profile form (ppf), the patient is deceased, however a cause of death nor a relationship to the device was provided.The patient's family reported becoming aware of blood clots, clotting, occlusion of the ivc and device unable to be retrieved, becoming aware of these events about nine years and eight months post implantation.The family additionally reports that the patient suffered from complications caused by the faulty ivc filter and the lifelong impact on the patient's health and mobility.The clot formation which occurred due to the ivc filter, and the inability to treat/remove the clot formation, became a stressful mental and physical ordeal.Multiple hospital stays (and transfers to and from), months of confinement to a basic care facility, continuous rehab therapy, and permanent loss of quality of life are just some of the impacts experienced.The patient suffered daily from leg swelling and ongoing pain/numbness, and sought treatment, both locally and out of state, for the leg issues/pain but never found any satisfaction or remedy.The patient was concerned about a relapse of the clot formation or incurring in further damage from the filter itself.The patient was never able to have the filter removed because the risk factor was too great, thus had to live with these concerns knowing a relapse could occur at any time.The clot formation and concern affected the patient's overall health and contributed to the patient's decline.

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Brand Name

OPTEASE RETRIEVAL FILTER

Type of Device

FILTER, INTRAVASCULAR, CARDIOVASCULAR

Manufacturer (Section D)

CORDIS CASHEL

cahir road

cashel, co. tipperary

miami FL

MDR Report Key

6120944

MDR Text Key

60686815

Report Number

1016427-2016-00124

Device Sequence Number

Product Code

DTK

Combination Product (y/n)

PMA/PMN Number

K034050

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

company representative,health

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

11/22/2016

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Model Number

466FXXXX

Device Catalogue Number

466F220A

Device Lot Number

R0404524

Was Device Available for Evaluation?

Distributor Facility Aware Date

10/31/2016

Date Manufacturer Received

06/30/2021

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Treatment

UNK.

Patient Outcome(s)

Life Threatening; Other;

Patient Age

82 YR

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

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