MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE VENA CAVA FILTER

Model Number N/A

Device Problems Difficult to Remove (1528); Failure to Align (2522)

Patient Problems Embolism (1829); Occlusion (1984); Thrombosis (2100); Ulcer (2274); Regurgitation, Valvular (2335)

Event Date 05/17/2012

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available.  if obtained, a follow up report will be submitted within 30 days upon receipt.As reported in a legal brief, a patient underwent placement of an optease vena cava filter which subsequently malfunctioned including but not limited to, post-implant pulmonary embolism, embedment of the filter in the ivc wall, multiple failed complex retrieval attempts, chronic venous insufficiency requiring venous ablation, filter unable to be retrieved, and lifetime anticoagulation.As a direct and proximate result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages, and required extensive medical care and treatment.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.  without procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined.Dates of implantation and attempted retrieval are unknown at this time.Retrieval of the optease vena cava filter is indicated up to 23 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the ifu as such.Patient condition and pharmacological factors may have contributed to the 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 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 legal brief, (b)(6) vs.Cordis, the patient underwent placement of an optease vena cava filter which reportedly subsequently malfunctioned including but not limited to, post-implant pulmonary embolism, embedment of the filter in the ivc wall, multiple failed complex retrieval attempts, chronic venous insufficiency requiring venous ablation, filter unable to be retrieved, and lifetime anticoagulation.   as a direct and proximate result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages, and required extensive medical care and treatment.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.The following additional information received per the patient profile from (ppf) indicates that the filter was tilted, the patient had blood clots, clotting, occlusion of the ivc and venous stasis ulcers.The patient also reports to be suffering from leg swelling, leg pain, stress and anxiety.According to the medical records, eight years and ten months post implantation the patient underwent an unsuccessful attempt to remove the filter percutaneously.Thirty-three days after that, the patient underwent a second unsuccessful attempt to remove the filter.Per the medical records, the patient had a history of pe.The patient was contraindicated for anticoagulation and required a gastric bypass.The filter was deployed below the renal veins without any reported complications and the patient tolerated the procedure well.A review of the manufacturing documentation associated with this lot (r1002049) presented no issues during the manufacturing process that can be related to the reported event.(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the medical records, the patient had a history of pulmonary embolism (pe).The patient was contraindicated for anti-coagulation and required a gastric bypass.The filter was deployed below the renal veins without any reported complications and the patient tolerated the procedure well.It was reported that the filter reportedly subsequently malfunctioned including but not limited to, post-implant pe, embedment of the filter in the inferior vena cava (ivc) wall, multiple failed complex retrieval attempts, chronic venous insufficiency requiring venous ablation, filter unable to be retrieved, and lifetime anticoagulation.As a direct and proximate result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages, and required extensive medical care and treatment.The following additional information received per the patient profile from (ppf) indicates that the filter was tilted, the patient had blood clots, clotting, occlusion of the ivc and venous stasis ulcers.The patient also reports to be suffering from leg swelling, leg pain, stress and anxiety.According to the medical records, eight years and ten months post implantation the patient underwent an unsuccessful attempt to remove the filter percutaneously.Thirty-three days after that, the patient underwent a second unsuccessful attempt to remove the filter.The product was not returned for analysis as it remains implanted.A review of the device history record 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.Without procedural films for review, the reported tilt and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Pe (pulmonary emboli) and blood clots and occlusive thrombosis within the filter do not represent a device malfunction.Venous stasis ulcers and chronic venous insufficiency with swelling of the legs and pain do not represent device malfunctions and maybe related to underlying patient comorbidities.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.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 VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6511321
• MDR Text Key: 73375608
• Report Number: 1016427-2017-00272
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2005
• Device Model Number: N/A
• Device Catalogue Number: 466F220A
• Device Lot Number: R1002049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/27/2017
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 59 YR