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 (15487383) 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 device¿s inter alia, caused leg aches and shortness of breath.As a result of the malfunction, the patient has suffered life-threatening injuries and damages and requires extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.The following additional information received per the patient profile from (ppf) indicates that on or about three years and six months post implantation the device was unable to be retrieved, although there have been no known recorded attempts to remove the filter.The patient also reports to be suffering from anxiety and panic.According to the medical records, the indication for the procedure was suspicion of pulmonary embolism (pe) and the patient was not a candidate for anticoagulation.The filter was successfully deployed in the infrarenal inferior vena cava (ivc).

Manufacturer Narrative

After further review of additional information received the sections have been updated accordingly.As reported, the patient underwent placement of an optease retrievable inferior vena cava (ivc) filter.Per the medical records, the indication for the procedure was suspicion of pulmonary embolism (pe) and the patient was not a candidate for anti-coagulation.The filter was successfully deployed in the infrarenal inferior vena cava (ivc).The device caused leg aches and shortness of breath.Because of the malfunction, the patient has suffered life-threatening injuries and damages and requires extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.The following additional information received per the patient profile from (ppf) indicates that on or about three years and six months post implantation the device was unable to be retrieved, although there have been no known recorded attempts to remove the filter.The patient also reports to be suffering from anxiety and panic.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 predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Shortness of breath and leg aches do not represent device malfunctions and may be related to underlying patient related issues.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.

• 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: 7144016
• MDR Text Key: 95724209
• Report Number: 9616099-2017-01718
• 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 Expiration Date: 09/30/2014
• Device Catalogue Number: 466F220A
• Device Lot Number: 15487383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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): Life Threatening; Disability
• Patient Age: 73 YR