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

Catalog Number 466F220A

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

Patient Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Perforation (2001); Thrombosis (2100)

Event Date 04/23/2013

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Date of event: please note that the exact event date is unknown and the event date is the complaint awareness date.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.Additional information is pending and will be submitted within 30 days of receipt.

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 post implantation deep vein thrombosis and post implantation pulmonary embolism.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.Additional information received per the medical records indicate that the patient has a history of bilateral deep vein thrombosis.The filter was deployed via the left groin.It was placed at the l2-l3 level.The filter aligned properly with the inferior vena cava.There were no complications.The patient was in stable condition after the procedure.Four years and eleven months after the index procedure, the patient presented with recurrent pulmonary embolus.At that time the patient had an emboli in the right lung.It was noted that the patient was in stable condition, but a second filter would be implanted.The second filter was placed via the right common femoral vein with ultrasound guidance.A venography revealed that the previously placed cordis filter was well positioned in the inferior vena cava.There may have been some residual thrombus in the filter, but this was uncertain.Because of recurrent events with repeated pulmonary embolization, a second filter by a different manufacturer was implanted.The second filter was deployed through a delivery sheath inferior to the previous filter but cephalad to the bifurcation into the common iliac veins.A follow up venography confirmed that the second filter was centered in a position below the cordis filter.The patient tolerated the procedure well and there were no complications.  additional information received per the patient profile form (ppf) states that the patient experienced post implantation deep vein thrombosis, post implantation pulmonary embolism, blood clots, clotting and or occlusion of the inferior vena cava (ivc).The patient continues to experience worry, mental anguish and fear.  as reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of bilateral deep vein thrombosis (dvt) and pulmonary embolus (pe) despite anticoagulation therapy.The filter was implanted via the left groin and placed at the level of l2-l3 without complication.Approximately four years and eleven months after the implantation, the patient experienced a pe in the right lung, dvt, blood clots, clotting and/or occlusion of the inferior vena cava (ivc).Venography revealed that the previously implanted optease retrievable vena cava filter was well positioned within the ivc.This filter was noted to have possible residual thrombus within it.A non-cordis filter was implanted via the right common femoral vein above the iliac bifurcation and below the previously implanted cordis filter.The patient is reported to have tolerated the procedure well and without complication.The patient further reported having experienced worry, mental anguish, anxiety and fear 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.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 instructions for use (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.Occlusion within the ivc and/or vasculature does not represent a device malfunction.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, unease and worry.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

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for filter placement is not available.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to post implantation deep vein thrombosis and post implantation pulmonary embolism.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.Post procedural dvt and pulmonary embolism are known potential events associated with the use of the filter devices.Patent specific factors, specifically the underlying causes for thrombus formation, can contribute to these events.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

After further review of additional information received, the following sections have been updated accordingly: b1, b4, g4, g7, h1, h2 and h6.Section h6: patient code '2001' was used for "perforation of the filter struts outside the inferior vena cava and perforation into the l4-l5 disc".Section b5: the results of computed tomography (ct) scans done approximately eleven years and two months after the index procedure indicate that the patient has two filters in place and both show tilting.The more superior filter (the cordis device) has anchoring legs that extend 1 mm through the inferior vena cava (ivc) wall.There is no evidence of facture or bending.The more inferior filter's anterior anchoring legs (second filter by a different manufacturer) extend, at most, 1 mm though the ivc wall.Two of the posterior anchoring legs extend 7mm and 3 mm beyond the wall of the ivc.The longer of these legs contact the anterior margin of the l4-l5 disc.The report states that the anchoring legs extend through the ivc wall, but do not appear to contact critical structures.The scans found that the patient has a residual hiatal hernia following a previous gastric surgery.Additional information received per an amended patient profile form (ppf) states that the patient experienced perforation of the filter struts outside the inferior vena cava, tilting of the filter and perforation into the l4-l5 disc.However, the ct scan clarified that the legs of the more inferior vena cava filter was in contact with the margin of the l4-l5 disc.Previous medical records revealed that the more inferior filter was from a different manufacturer.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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, g4, g7, h1, h2 and h6.Section b5: as reported, the patient had placement of an optease inferior vena cava (ivc) filter.Per the medical records.History includes bilateral deep vein thrombosis.The filter was deployed at the l2-l3 level.The filter was aligned properly with the inferior vena cava.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to post implantation deep vein thrombosis and post implantation pulmonary embolism.Four years and eleven months after implant, the patient presented with recurrent pulmonary embolus in the right lung.The second non-cordis filter was placed.Venography revealed that the cordis filter was well positioned in the inferior vena cava with some residual thrombus in the filter.The second filter was deployed inferior to the cordis filter but above to the bifurcation into the common iliac veins.A follow up venography confirmed that the second filter was centered in a position below the cordis filter.Per the patient profile form (ppf), the patient reports post implantation deep vein thrombosis, post implantation pulmonary embolism, blood clots, clotting and or occlusion of the inferior vena cava (ivc), perforation of the filter struts outside the ivc, and filter tilt.The patient also reports worry, mental anguish and fear.A ct scan, approximately eleven years post implant, indicate two filters in place and both show tilting.The more superior filter (the cordis device) has anchoring legs that extend 1 mm through the inferior vena cava (ivc) wall.There is no evidence of facture or bending.The non-cordis filter's anterior anchoring legs extend, at most, 1 mm though the ivc wall.Two of the posterior anchoring legs extend 7mm and 3 mm beyond the wall of the ivc.The longer of these legs contact the anterior margin of the l4-l5 disc.The scan also found that the patient has a residual hiatal hernia following a previous gastric surgery.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.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.Post procedure pulmonary embolism is a known potential adverse event associated with the use of the ivc filters.These events may be related to excessive clot burden from underlying patient specific factors.Blood clots, dvt 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: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8310749
• MDR Text Key: 135177722
• Report Number: 1016427-2019-02478
• 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,Followup,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466F220A
• Device Lot Number: R0408102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2019
• Patient Sequence Number: 1
• Treatment: UNKNOWN INTRODUCER SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 56 YR