MAUDE Adverse Event Report: CORDIS CORPORATION FEMORAL 55CM KIT; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466F230AF

Device Problems Therapeutic or Diagnostic Output Failure (3023); Unintended Movement (3026)

Patient Problems Coagulation Disorder (1779); Stenosis (2263); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused caval thrombosis and deep vein thrombosis.The indication for the filter implant, procedural details and medical history of the patient have not been provided.There is currently no additional information available for review.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 ivc 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 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, clotting and/or occlusive thrombosis within the filter and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Ivc filters are not indicated for use in the prevention of dvt.With the limited information provided a clinical determination cannot be made as to what factors may have contributed to the reported events.There is nothing to suggest that the reported events are related to the design and/or 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, a 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 caval thrombosis and deep vein thrombosis.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused caval thrombosis and deep vein thrombosis.The patient reported becoming aware of blood clots, clotting and occlusion of the inferior vena cava (ivc), approximately ten months post implant.The patient also reported anxiety related to the filter.According to the implant record, the patient was reported to have a past medical history of peripheral vascular disease and was status post left below the knee amputation, who then presented with shortness of breath and chest pain and was found to have submasssive bilateral pulmonary emboli (pe).The filter was indicated after a lower extremity doppler revealed a left femoral vein deep vein thrombosis (dvt).The filter was placed via the right femoral vein and was successfully deployed in the ivc at the level of l2 to l3.A pre-deployment right iliofemoral venogram and an inferior vena cava (ivc) venogram demonstrated a widely patent ivc with no thrombus; the right iliac vein showed no occlusive clot.The optease filter was successfully deployed in the ivc at the level of l2 to l3.The patient tolerated the procedure well.There is currently no additional information available for review.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 ivc 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 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, clotting and/or occlusive thrombosis within the filter and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.With the limited information provided a clinical determination cannot be made as to what factors may have contributed to the reported events.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.There is nothing to suggest that the reported events are related to the design and/or 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, a 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 caval thrombosis and deep vein thrombosis.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the patient was reported to have a past medical history of peripheral vascular disease and was status post left below the knee amputation (bka), who then presented with shortness of breath and chest pain and was found to have submasssive bilateral pulmonary emboli (pe).The filter was indicated after a lower extremity doppler revealed a left femoral vein deep vein thrombosis (dvt).The right groin was prepped and draped in the usual sterile fashion, and the right femoral vein was accessed with a needle.A right iliofemoral venogram and an inferior vena cava (ivc) venogram were performed, demonstrating a widely patent inferior vena cava with no thrombus pre filter deployment; the right iliac vein showed no occlusive clot.The optease filter was successfully deployed in the ivc at the level of l2 to l3.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient reports blood clots, clotting and occlusion of the ivc, becoming aware of these events approximately ten months after the filter implantation.The patient further experienced anxiety related to the filter.

Manufacturer Narrative

As reported, a patient underwent placement of an optease inferior vena cava (ivc) filter.Per the implant records, the indication was sub-massive pe (pulmonary embolus).Medical history includes peripheral vascular disease and s/p left below the knee amputation (bka).Doppler at the time revealed a left femoral vein dvt.A venocavogram located the renal veins and assessed the caliber of the ivc.The filter was successfully deployed in an infrarenal position.There were no reports of complications.The filter malfunctioned including ivc thrombosis and deep vein thrombosis (dvt).Per the patient profile form (ppf), the patient reports tilting of the filter, stenosis, blood clots, clotting and occlusion of the ivc, and anxiety related to the filter.The filter remains implanted thus unavailable for analysis.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.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Permanent ivc filters have been reported to obstruct in up to 20% of patients.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.

Event Description

As reported in the legal brief, a 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 caval thrombosis and deep vein thrombosis.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the patient was reported to have a past medical history of peripheral vascular disease and was status post left below the knee amputation (bka), who then presented with shortness of breath and chest pain and was found to have submasssive bilateral pulmonary emboli (pe).The filter was indicated after a lower extremity doppler revealed a left femoral vein deep vein thrombosis (dvt).The right groin was prepped and draped in the usual sterile fashion, and the right femoral vein was accessed with a needle.A right iliofemoral venogram and an inferior vena cava (ivc) venogram were performed, demonstrating a widely patent inferior vena cava with no thrombus pre filter deployment; the right iliac vein showed no occlusive clot.The optease filter was successfully deployed in the ivc at the level of l2 to l3.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient reports blood clots, clotting and occlusion of the ivc, becoming aware of these events approximately ten months after the filter implantation.The patient further experienced anxiety related to the filter.According to the information received in the redacted patient profile form (ppf), the patient additionally reports becoming aware of tilting of the filter, stenosis and that the ivc filter remains implanted despite requests from the patient to have the filter removed.

• Brand Name: FEMORAL 55CM KIT
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• MDR Report Key: 11392233
• MDR Text Key: 234018762
• Report Number: 1016427-2021-04782
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K140286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 466F230AF
• Device Lot Number: 17592407
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 03/18/2021; 05/19/2021
• Supplement Dates FDA Received: 04/02/2021; 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO 6F 10CM PRECISION SHEATH; UNK NEEDLE, UNK 0.35 J-TIP
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR
• Patient Weight: 88