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

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problems Coagulation Disorder (1779); Occlusion (1984)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 6-french long cordis optease introducer sheath.The product remains implanted and is thus not available for analysis.A review of the manufacturing records could not be conducted without a lot number.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported in the legal brief, an unspecified period of time after an optease vena cava filter was implanted, the filter subsequently malfunctioned and caused injury and damage, including, but not limited to: blood clots, clotting, and/or occlusion of the ivc.Additional information provided on the patient profile form (ppf) indicated that the patient has experienced blood clots, clotting, and/or occlusion of the ivc, in addition "toe" dvt and pe requiring hospitalization.The patient became aware of these events approximately one year and eight months post implant.The patient reported that these events have led to anxiety disorders, depression and sleep disorders.Information contained in the medical records indicated that the filter was placed for known deep vein thrombosis (dvt) extending above the left popliteal vein and recent massive pulmonary embolism (pe).The filter was placed via the right common femoral vein and deployed between the renal and iliac veins.The patient tolerated the procedure well without any complications.The patient denied any health history prior to the placement of the filter.The patient does report an allergy to yellow fever vaccine.On the day of the procedure, ct angiogram of the chest showed further interval reduction in clot burden with subacute pe, largest in the right lower lobar vessel, no new findings.Approximately 2 months later a ct angiogram of the chest was performed for shortness of breath and chest pain.The findings noted some residual old subacute thrombotic material in the right lower lobe pulmonary artery, no new or recurrent emboli seen.A doppler study was also performed and noted partial compression of echogenic material noted in the left popliteal vein.Approximately 10 months later, follow up visit with cardiologists, the patient reported rather severe depression and going to a psychiatrist.The patient's pharmacy receipts indicate he was taking "bupronin" but the medical records do not provide any further details.4 months later, ct angiography of the chest was performed for complaints of chest pain, results found no evidence of pe.A doppler study of the lower extremities showed no evidence of acute dvt or superficial thrombosis in the right lower extremity, chronic dvt noted in the left popliteal vein.3 months later, a doppler study of the lower extremities showed no evidence of thrombus in the right lower extremity, and chronic appearing thrombus in the left popliteal vein.9 months later, the patient was admitted to the hospital with complaints of increased shortness of breath and right lower extremity swelling.The patient was not on coumadin at the time of admission.Doppler study was positive for dvt and a computed tomography (ct) scan of the chest was positive for bilateral pe, with a moderately large amount of clot burden in the pulmonary arteries, bilaterally.The patient was discharged two days later.During a follow up visit approximately 1 week later, it was noted that the patient was quite limited in physical activity due to chest pain and shortness of breath, the medical record indicates that is related to the pulmonary embolism.A doppler study of the lower extremities two months later showed no evidence of thrombus in the right lower extremity, and chronic appearing thrombus in the left popliteal vein.A ct scan of the chest was performed for complaints of chest pain two months later and the findings showed no acute processes and prior pe¿s had resolved.Approximately 6 ½ months later, the patient went to the hospital with complaints of atypical chest pain.The patient¿s workup was negative and was discharged the same day.

Manufacturer Narrative

As reported, after an optease inferior vena cava filter was implanted, the filter subsequently malfunctioned and caused injury and damage, including, but not limited to: blood clots, clotting, and/or occlusion of the ivc.Per the medical records, the filter was placed for known deep vein thrombosis (dvt) extending above the left popliteal vein and recent massive pulmonary embolism (pe).The filter was deployed between the renal and iliac veins.The patient tolerated the procedure well without any complications.On the day of the procedure, ct angiogram of the chest showed further interval reduction in clot burden with subacute pe, largest in the right lower lobar vessel, no new findings.Additional information provided on the patient profile form (ppf)indicated that the patient has experienced blood clots, clotting, and/or occlusion of the ivc, in addition to dvt and pe requiring hospitalization.The patient reported that these events have led to anxiety disorders, depression and sleep disorders.Approximately 2 months after filter placement, a ct angiogram of the chest was performed for shortness of breath and chest pain.The findings noted some residual old subacute thrombotic material in the right lower lobe pulmonary artery, no new or recurrent emboli seen.A doppler study was also performed and noted partial compression of echogenic material noted in the left popliteal vein.Approximately 10 months later, follow up visit with cardiologists, the patient reported rather severe depression and going to a psychiatrist.The patient's pharmacy receipts indicate he was taking bupronin but the medical records do not provide any further details.4 months later, ct angiography of the chest was performed for complaints of chest pain, results found no evidence of pe.A doppler study of the lower extremities showed no evidence of acute dvt or superficial thrombosis in the right lower extremity, chronic dvt noted in the left popliteal vein.3 months later, a doppler study of the lower extremities showed no evidence of thrombus in the right lower extremity, and chronic appearing thrombus in the left popliteal vein.9 months later, the patient was admitted to the hospital with complaints of increased shortness of breath and right lower extremity swelling.The patient was not on coumadin at the time of admission.Doppler study was positive for dvt and a computed tomography (ct) scan of the chest was positive for bilateral pe, with a moderately large amount of clot burden in the pulmonary arteries, bilaterally.The patient was discharged two days later.During a follow up visit approximately 1 week later, it was noted that the patient was quite limited in physical activity due to chest pain and shortness of breath, the medical record indicates that is related to the pulmonary embolism.A doppler study of the lower extremities two months later showed no evidence of thrombus in the right lower extremity, and chronic appearing thrombus in the left popliteal vein.A ct scan of the chest was performed for complaints of chest pain two months later and the findings showed no acute processes and prior pe¿s had resolved.Approximately 6 ½ months later, the patient went to the hospital with complaints of atypical chest pain.The patient¿s workup was negative and was discharged the same day.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.Blood clots, post procedural pe, thrombosis of the pulmonary artery and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Swelling of the limbs does not represent a device malfunction and may be related to underlying patient related issues.Chest pain, shortness of breath, depression and anxiety 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.

• Brand Name: UNKNOWN OPTEASE RETREIVABLE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• MDR Report Key: 8081320
• MDR Text Key: 127548700
• Report Number: 1016427-2018-02271
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K023116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.035 J-TIPPED GUIDEWIRE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 130