MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER; THROMBECTOMY SYSTEMS

Model Number N/A

Device Problem Occlusion Within Device (1423)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); No Code Available (3191)

Event Date 12/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available.Patient demographics were not provided.If obtained, a follow up report will be submitted within 30 days upon receipt.As reported, the patient underwent placement of an optease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots and recurrent deep vein thrombosis (dvt).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, and pain and suffering, and other damages.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 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).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.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 in the legal brief, the patient underwent placement of an optease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots and recurrent deep vein thrombosis (¿dvt¿).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, and pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.The following additional information received per the medical records indicate that the patient has a history of morbid obesity and referred for filter placement due to impending gastric bypass surgery.During the implantation procedure, the filter was placed in good position at the upper level of l3.The patient tolerated the procedure well and sent to recovery in stable condition.According to the information received in the patient profile form (ppf) indicates that the patient became aware of the reported events on or about nine years and nine months post implantation.The patient also reports to be suffering from clotting, occlusion of the inferior vena cava (ivc), venous insufficiency, swelling, pain, leg ulcers and being unable to walk.(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

The device¿s expiration is february 2008.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of morbid obesity and referred for filter placement due to impending gastric bypass surgery.During the implantation procedure, the filter was placed in good position at the upper level of l3.The patient tolerated the procedure well and sent to recovery in stable condition.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots and recurrent deep vein thrombosis (dvt).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, and pain and suffering, and other damages.According to the information received in the patient profile form (ppf) indicates that the patient became aware of the reported events on or about nine years and nine months post implantation.The patient also reports to be suffering from clotting, occlusion of the inferior vena cava (ivc), venous insufficiency, swelling, pain, leg ulcers and being unable to walk.The product was not returned for analysis as it remains implanted.A review of the device history record (dhr) associated with lot r0305019 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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, dvt (deep vein thrombosis) and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Venous insufficiency, pain, swelling, ulcers of the leg and difficulty walking do not represent device malfunction and maybe related to the underlying patient condition.Clinical factors that may have influenced the event include patient, specifically coagulopathy, 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.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: THROMBECTOMY SYSTEMS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• MDR Report Key: 7212137
• MDR Text Key: 97978631
• Report Number: 1016427-2018-01065
• 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: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• 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: 466F220A
• Device Lot Number: R0305019
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/28/2017
• Date Manufacturer Received: 02/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 51 YR