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

Model Number 466FXXXX

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

Patient Problem Stenosis (2263)

Event Date 12/20/2021

Event Type  Injury  

Event Description

As reported by the legal department, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, stenosis.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused stenosis.The indication for the filter implant, procedural details and medical history of the patient have not been provided.There is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; 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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.Stenosis within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include possible pre-existing comorbidities, pharmacological and vessel characteristics.Without images available for review the reported event could not be confirmed or further clarified.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.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal department, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, stenosis.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.According to the information received in the patient profile form (ppf), the patient reports stenosis previously reported to cordis on (b)(6) 2021, becoming aware of these events approximately five years, nine months, and 20 days after the filter implantation.Further experienced anxiety, back and stomach pain related to the filter.Patient experienced an acute subdural hematoma due to a hit to the head and extreme stress related to pain.Per the implant records, patient has history of bilateral dvt, retroperitoneal hematoma and factor v deficiency.The physician got arterial access on the right side and then a venous access.After obtaining venous access with a 6-french unknown sheath was inserted and then inferior venacavogram was done.The physician stated that the demarcation in the bifurcation site of the common iliac veins, was a good landmark and deployed the ivc filter.After deploying the filter, a venacavogram was repeated.The physician was able to see with the venacavogram that the ivc was positioned perfectly without any issues.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused stenosis.The patient reported becoming aware of the event approximately five years and ten months post implant.The patient also reported anxiety, back and stomach pain related to the filter.According to the operative note, the indication for the filter implant was bilateral deep vein thrombosis (dvt), a retroperitoneal hematoma, and factor v deficiency.After some initial difficulty, venous access was obtained on the right side, a 6-french sheath was inserted and an ivc gram was performed.Due to back surgeries and an unspecified enlarged part of the anatomy, making a landmark was very difficult.The physician identified demarcation in the bifurcation site of the common iliac veins and used it as a landmark and deployed the filter.Post-deployment venacavogram showed the filter was positioned perfectly without any issues.The product remains implant and therefore not available for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.Stenosis within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include possible pre-existing comorbidities, pharmacological and vessel characteristics.Without images available for review the reported event could not be confirmed or further clarified.Anxiety is an emotion characterized by an unpleasant state of inner turmoil, often accompanied by nervous behavior, somatic complaints, and rumination.The physiological symptoms of anxiety may include, but are not limited to neurological, respiratory, cardiac, muscular, and cutaneous.Due to the nature of the complaint the reported stomach and back pain could not be further clarified.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.Additionally, the patient had a history of back surgeries.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.Should additional information become available, the file will be updated accordingly.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13281481
• MDR Text Key: 283954047
• Report Number: 9616099-2022-05303
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009416
• UDI-Public: (01)20705032009416(17)170531(10)17046690
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Device Lot Number: 17046690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 6 FR UNKNOWN SHEATH.; UNK.
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 65 KG