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

Catalog Number 466F220A

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

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot (r0508076) presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent placement of an optease retrievable vena cava filter.The following additional information received per the patient profile from (ppf) indicates that the device is unable to be retrieved although there have been no known attempts to retrieve the filter on record.The patient also reports to be suffering from swelling in the leg causing pain and mental anguish.According to the medical records, the diagnosis indication for the procedure was thrombolysis.The patient was high risk for deep vein thrombosis (dvt), pulmonary embolism (pe), hypertension and diabetes.

Manufacturer Narrative

After further review of additional information received the sections have been updated accordingly.It was reported that a patient underwent placement of an optease retrievable vena cava filter.The indication for the implant was a a diagnosis indication for thrombolysis, at risk for pulmonary embolism (pe) and deep vein thrombosis (dvt).The patient¿s medical history is also significant for hypertension and insulin dependent diabetes.The device was deployed via the right femoral vein with no reported complications.Additional information contained in the patient profile form indicated that the device was unable to be retrieved although there have been no known attempts to retrieve the filter on record.The patient also reports to be experiencing persistent swelling in the leg causing pain and mental anguish.There is currently no additional information available.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.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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.Without images or procedural films for review the reported embedded/retrieval difficulty could not be confirmed.Clinical factors that may influenced any potential events include underlying patient co-morbidities, pharmacological and lesion characteristics.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.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in swelling of the affected extremity, resulting in discomfort associated with the edema.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.With the limited information currently available for review it is not possible to determine what factors may have contributed to the reported events, there is also 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: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7143864
• MDR Text Key: 95728731
• Report Number: 9616099-2017-01716
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466F220A
• Device Lot Number: R0508076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 50 YR
• Patient Weight: 95