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 Problems Cardiac Arrest (1762); Death (1802); Edema (1820); Unspecified Infection (1930); Thrombosis (2100)

Event Date 06/14/2015

Event Type  Death  

Manufacturer Narrative

As reported by the legal brief, the patient on or about (b)(6) 2015 underwent placement of defendants¿ optease vena cava filter.On or about (b)(6) 2015, the filter subsequently malfunctioned and caused great bodily harm to the patient including but not limited to, a complete and total occlusion of the inferior vena cava, causing loss of internal blood flow, edema, infection, cardiac arrest and death.As a direct and proximate result of the malfunctions, the patient suffered fatal injuries, damages, and untimely death.The product was not returned for evaluation.Without a lot number to conduct a device history record (dhr) review, it is not possible to determine if the reported failure could be related to the manufacturing process.  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.Neither death, inferior vena caval occlusion, edema, infection, nor cardiac arrest represent a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.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 by the legal brief, the patient on or about (b)(6) 2015 underwent placement of defendants' optease vena cava filter.On or about (b)(6) 2015, the filter subsequently malfunctioned and caused great bodily harm to the patient including but not limited to, a complete and total occlusion of the inferior vena cava, causing loss of internal blood flow, edema, infection, cardiac arrest and death.As a direct and proximate result of the malfunctions, the patient suffered fatal injuries, damages, and untimely death.

Manufacturer Narrative

According to the medical records, the filter was placed as the patient previously had a bilateral saddle pulmonary embolism (pe) post a tissue plasminogen activator (tpa) infusion and subsequent hematoma in the right groin.The patient was being treated for a prolonged time at the hospital with multiple complications of bowel obstruction and was unable to be anticoagulated.The patient also had deep vein thrombosis (dvt) in the left leg.During the index procedure, the filter was deployed below the renal veins without any complications.The patient tolerated the procedure well.The following additional information received per the patient profile form (ppf) indicates that the patient also had blood clots and clotting and that the cause of death was the occlusion of the ivc.However, the autopsy report is not available.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the medical records, the filter was placed as the patient previously had a bilateral saddle pulmonary embolism (pe) post a tissue plasminogen activator (tpa) infusion and subsequent hematoma in the right groin.The patient was being treated for a prolonged time at the hospital with multiple complications of bowel obstruction and was unable to be anticoagulated.The patient also had deep vein thrombosis (dvt) in the left leg.During the index procedure, the filter was deployed below the renal veins without any complications.The patient tolerated the procedure well.Six days post implantation, the filter subsequently malfunctioned and caused great bodily harm to the patient including but not limited to, a complete and total occlusion of the inferior vena cava (ivc), causing loss of internal blood flow, edema, infection, cardiac arrest and death.As a direct and proximate result of the malfunctions, the patient suffered fatal injuries, damages, and untimely death.The following additional information received per the patient profile form (ppf) indicates that the patient also had blood clots and clotting and that the cause of death was the occlusion of the ivc.However, the autopsy report is not available.The product was not returned for analysis as it remains implanted.A review of the device history record (dhr) associated with lot 15836564 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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Edema does not represent a device malfunction and may be related to underlying patient related issues.Infection does not represent a device malfunction and may be related to underlying patient related issues.Cardiac arrest is a known potential adverse event associated with the use of the ivc filter; however, with the limited information it is not possible to make a conclusion regarding the root cause of the infarction and death.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: 6714541
• MDR Text Key: 80064111
• Report Number: 1016427-2017-00456
• 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: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 466F220A
• Device Lot Number: 15836564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2013
• 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): Death
• Patient Age: 47 YR