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

Catalog Number 466F220B

Device Problem Occlusion Within Device (1423)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombosis (2100)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

The device¿s expiration date is april 2009.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 vena cava filter.The following additional information received per the patient profile from (ppf) indicates that the filter is clogged up, is embedded in the inferior vena cava (ivc) and that it was unable to be retrieved.However, there have been no known attempts to remove the filter.The patient also reports to have blood clots, clotting, occlusion of the ivc, permanent discoloration in both legs, and to be suffering from anxiety.According to the medical records, the indication for the procedure was deep vein thrombosis (dvt) and pulmonary embolism (pe).The patient had a recent motor vehicle crash (mvc) and had left lower extremity venous thrombosis.The filter was deployed below the renal veins without any reported complications.The patient tolerated the procedure well.

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 indication for the procedure was deep vein thrombosis (dvt) and pulmonary embolism (pe).The patient had a recent motor vehicle crash (mvc) and had left lower extremity venous thrombosis.The filter was deployed below the renal veins without any reported complications.The patient tolerated the procedure well.Per the patient profile from (ppf), the filter is clogged up, is embedded in the inferior vena cava (ivc) and that it was unable to be retrieved.However, there have been no known attempts to remove the filter.The patient also reports to have blood clots, clotting, occlusion of the ivc, permanent discoloration in both legs, and to be suffering from anxiety.The product was not returned for analysis as it remains implanted.A review of the device history record (dhr) associated with lot r0406638 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 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Skin discoloration does not represent a device malfunction 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: 7261042
• MDR Text Key: 99765244
• Report Number: 1016427-2018-01153
• 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: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466F220B
• Device Lot Number: R0406638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 02/10/2018
• Supplement Dates FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2006
• 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
• Patient Age: 32 YR