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

Catalog Number 466FXXXX

Device Problems Failure to Align (2522); Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Necrosis (1971); Occlusion (1984); Thrombosis (2100); No Consequences Or Impact To Patient (2199); Hematuria (2558); No Code Available (3191)

Event Date 12/31/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.At some point after the implantation, the patient became aware that the filter had tilted.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (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 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.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 an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including but not limited to tilt of the filter.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.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a recent history of pulmonary embolism (pe) that was treated with thrombolysis followed by systemic anticoagulation therapy.The patient subsequently developed left knee hemarthrosis that was treated with drainage and cessation of anticoagulation therapy.The indication for the filter placement was reported to be massive bilateral pe and bleeding with contraindication to further anticoagulation.The filter was implanted via the right common femoral vein and placed in an infrarenal location.The patient is reported to have tolerated the procedure well and without complication.Approximately sixteen days after filter implantation, the patient presented with recurrent syncope.A computerized tomography (ct) scan revealed no evidence of new deep vein thrombosis (dvt).Approximately nineteen days after filter implantation, the patient developed a right femoral dvt.Six days later, the patient developed a further dvt in the left femoral vein along with severe leg pain and massive swelling.Approximately one month after filter implantation, the patient was noted to have acute dvt of the bilateral popliteal, femoral and iliac veins.The inferior vena cava (ivc) and filter were also noted to be occluded.The patient was treated with mechanical thrombectomy with marked improvement and debulking of the thrombus.The patient was also treated with directed thrombolysis into each popliteal vein.By the following morning, venography demonstrated marked improvement in both femoral and iliac veins, and in the ivc.There was some residual thrombus in the ivc that was noted to be non-obstructive.Post-procedure, the patient developed acute tubular necrosis that was treated with sodium bicarbonate and intravenous fluids.The patient also developed anemia requiring treatment with a blood treatment.The patient was noted to have bleeding into the left leg popliteal fossa.Over the next few days, the patient¿s leg improved.The patient experienced persistent hematuria.A ct scan revealed findings consistent with contrast-induced nephrotoxicity.Approximately ten and a half years after filter implantation, the patient underwent a ct scan that revealed that the filter had an approximately 23-degree leftward tilt with the inferior margin of the filter contacting the right lateral wall of the ivc.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 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 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.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.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 thrombectomy, tubular necrosis, bleeding and hematuria 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.

Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including but not limited to tilt of the filter.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.Per the medical records provided, sometime before filter placement, the patient developed pulmonary embolism; was treated with iv thrombolysis and was subsequently started on systemic anticoagulation and sent home.The patient later developed left knee hemarthrosis which required drainage and cessation of anticoagulation, and the patient underwent placement of an inferior vena cava filter.Anticoagulation was held due to the high risk of recurrent hemarthrosis.Per the patient¿s implant records, patient¿s preoperative diagnosis included massive bilateral pulmonary embolism, status post systemic thrombolytic therapy and subsequent left knee hemarthrosis.The optease retrievable filter was deployed without difficulty to the inferior vena cava.The renal veins were superior to the filter.The patient tolerated the procedure well without any complications.Approximately sixteen days after the filter was implanted, the patient was readmitted with recurrent syncope.A computerized tomography (ct) scan of the chest did not show new deep venous thrombosis (dvt).Approximately nineteen days post implant, the patient developed right femoral dvt, and six days later, developed a left femoral vein deep venous thrombosis along with severe pain in the legs from the massive swelling.Additional evaluation and treatment were completed approximately one-month after implantation.Using venography, via bilateral popliteal vein access, it demonstrated acute dvt of both popliteal and femoral veins, as well as bilateral iliac veins.The ivc and inferior vena cava filter were also occluded.At that time, the patient underwent mechanical thrombectomy with an angiojet catheter, which resulted in marked improvement and debulking of the thrombus bilaterally; the patient also underwent catheter directed tissue plasminogen activator (tpa) administration via each popliteal vein.The following morning, venography demonstrated marked improvement in both femoral and iliac veins as well as ivc.There was some residual thrombus in the ivc; however, but it was non obstructive.The sheaths were removed, and the patient started on heparin.Subsequent to the procedure, the patient developed acute tubular necrosis with creatinine peaking, and was treated with sodium bicarbonate and intravenous (iv) fluids.A transfusion was necessary due to bleeding in the popliteal fossa of the left leg.Over the next few days, the legs started to improve.Nephrology was consulted due to persistent hematuria which occurred with anticoagulation.Although hematuria was expected following mechanical thrombectomy, hematuria from that etiology should resolve within 24 hours.The patient underwent a computerized scan (ct) scan of the abdomen and pelvis without iv contrast, which demonstrated delayed, striated nephrogram consistent with contrast -induced nephrotoxicity.Underlying pyelonephritis could not be excluded, and clinical correlation was recommended.The patient did not have fevers or findings that would right suggest clinical pyelonephritis and was also found to have some renal stones.Ultrasound of the kidneys was performed showing mild increase in renal echogenicity, which was nonspecific but consistent with medical renal disease.On the day of discharge, the patient was doing well; denied any pain and stated that that the legs were feeling much better compared to the first admission day.Nephrology and neurology both recommended oral antibiotics with amoxicillin and continue use of coumadin.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately ten years post implantation.The patient reports tilting of the ivc filter.

• Brand Name: UNKNOWN OPTEASE FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8862096
• MDR Text Key: 153798406
• Report Number: 1016427-2019-03124
• 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,other
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 5F PIGTAIL CATHETER; UNK 5F SHORT SHEATH
• Patient Age: 73 YR