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

Catalog Number 466F220A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolus (1830); Occlusion (1984); Swelling (2091); Thrombosis (2100)

Event Date 05/12/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient was implanted with a trapease vena cava filter.The filter subsequently malfunctioned and caused injury, damage including, but not limited to deep vein thrombosis (dvt) and post thrombotic syndrome.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As further proximate results, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.The inferior 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 that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Deep vein thrombosis (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.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).Post thrombotic syndrome is a problem that can develop in nearly half of all patients who experience a dvt.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities.The presence of these clots do not represent a device malfunction.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation 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 was implanted with a trapease® vena cava filter.The filter subsequently malfunctioned and caused injury, damage including, but not limited to deep vein thrombosis (dvt) and post thrombotic syndrome 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 results, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly.Additional information received per the medical records indicate that the patient has a history of chronic lower extremity deep vein thrombosis (left femoral and popliteal vein deep vein thrombosis).The records noted that the patient had progression of a left femoral-popliteal deep vein thrombosis into a left iliofemoral- popliteal deep vein thrombosis while he was on coagulation therapy.Also, prior to the index procedure, the patient had a left greater saphenous vein ablation.The filter was deployed just below the lowest right renal vein.The patient tolerated the procedure without hemodynamic or respiratory problems.The procedure was uncomplicated.Additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting and occlusion of the inferior vena cava.The form also states that the patient experienced loss of general health/strength, weakness, limited walking, limited standing, ulcers on his left ankle, swollen feet, swollen legs, bulging veins in legs, bulging veins in abdomen, pain, pain in groin area, erectile dysfunction, depression and anxiety.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

Section b5: as reported, the patient was implanted with a trapease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of chronic lower extremity deep vein thrombosis (left femoral and popliteal vein deep vein thrombosis).The records noted that the patient had progression of a left femoral-popliteal deep vein thrombosis into a left iliofemoral- popliteal deep vein thrombosis while he was on coagulation therapy.Also, prior to the index procedure, the patient had a left greater saphenous vein ablation.The filter was deployed just below the lowest right renal vein.The patient tolerated the procedure without hemodynamic or respiratory problems.The procedure was uncomplicated.The filter subsequently malfunctioned and caused injury, damage including, but not limited to, deep vein thrombosis (dvt) and post thrombotic syndrome.Per the patient profile form (ppf), the patient experienced blood clots, clotting and occlusion of the inferior vena cava.The form also states that the patient experienced loss of general health/strength, weakness, limited walking, limited standing, ulcers on his left ankle, swollen feet, swollen legs, bulging veins in legs, bulging veins in abdomen, pain, pain in groin area, depression and anxiety.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 trapease 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, clotting, post thrombotic syndrome and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Swelling of the legs, skin ulcers, distended veins and pain do not represent device malfunction and may be related to underlying patient specific issues.Anxiety and depression 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: OPTEASE RETRIEVAL FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7582590
• MDR Text Key: 110488678
• Report Number: 1016427-2018-01525
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 466F220A
• Device Lot Number: 15647053
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6-FRENCH SHEATH; UNKNOWN GUIDEWIRE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 64 YR