MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

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

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Chest Pain (1776); Dyspnea (1816); Occlusion (1984); Respiratory Distress (2045); Thrombosis (2100)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the plaintiff is a citizen and resident of the state of (b)(6).The plaintiff underwent placement of defendants' optease vena cava filter on or about (b)(6) 2005 in (b)(6).The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, severe and constant chest pains and compromised respiratory system.As a direct and proximate result of these malfunctions, the plaintiff suffered serious injuries and damages and will require extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.The product was not returned for evaluation as it remains implanted.The abovementioned product¿s catalog and lot numbers are not currently available.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 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.There are possible patient and pharmacological factors that may have contributed to the reported events of severe and constant chest pains and compromised respiratory system.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported 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 plaintiff is a citizen and resident of the state of (b)(6).The plaintiff underwent placement of defendants' optease vena cava filter on or about (b)(6) 2005 in (b)(6).The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, severe and constant chest pains and compromised respiratory system.As a direct and proximate result of these malfunctions, the plaintiff suffered serious injuries and damages and will require extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.It was reported that a patient underwent placement of an optease vena cava filter.It was reported that the filter subsequently malfunctioned and the patient is experiencing severe and constant chest pains and compromised respiratory system, clotting, occlusion of the inferior vena cava filter (ivc), retrieval difficulty, shortness of breath and anxiety.The indication for the implant was a retroperitoneal bleed.The device was implanted via the right internal jugular vein.The medical notes indicated that the filter was well positioned in the ivc below the level of the renal veins.Following the ivc filter implant a temporary dialysis catheter was placed at the access site used for the filter placement.Information contained in the patient profile form indicated that the filter was unable to be retrieved and that there were blood clots, clotting and or occlusion of the ivc.There were no documented retrieval attempts provided.There is currently no additional information available.The product was not returned for analysis and the sterile lot number provided is invalid; therefore, no device analysis nor device history record review could be performed.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 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 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 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, resulting in swelling/edema/bulging of the effected extremity(s).Blood clots, thrombosis in the filer and occlusion of the ivc do not represent a device malfunction, rather clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Without the procedural films or post-placement imaging and the limited information provided, the report of retrieval difficulty, blood clots, clotting and occlusion of the inferior vena cava (ivc) filter could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn.Chest pain, anxiety, shortness of breath, and a compromised respiratory system do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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.Should additional information become available, the file will be updated accordingly.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days of this report.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• MDR Report Key: 6362758
• MDR Text Key: 68466236
• Report Number: 1016427-2017-00198
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: R0506860
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/31/2017
• Date Manufacturer Received: 01/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 64 YR