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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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CORDIS CORPORATION 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problems Difficult to Remove (1528); Positioning Problem (3009)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 07/01/2018
Event Type  Injury  
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 embedment of the filter which is unable to be retrieved.The indication for the filter implant, procedural details and medical history of the patient have not been provided and 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 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.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implant.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization, 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 lead to explant problems after as short a period as 12 days.Clinical factors that may have influenced the event include patient and/or vessel characteristics.Without images for review and the limited information provided the reported event(s) could not be confirmed or further clarified.It is unknown how long the ivc filter has been implanted.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 in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to embedment of the filter which is unable to be retrieved.As a direct and proximate result of these malfunctions, 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 embedment of the filter which is unable to be retrieved.The patient reported becoming aware of the filter being unable to be retrieved approximately five years and seven months post implant.An unsuccessful percutaneous removal attempt was performed approximately nine months post implant, details of the procedure were not provided.The patient also reports chest pain and anxiety related to the filter.According to the implant record the indication for the filter implant was left lower extremity deep vein thrombosis and bilateral pulmonary embolism following a left tibial-fibula fracture.The filter was placed via the right common femoral vein and deployed with the distal tip at the bottom of l1 (to the level of the renal veins) after selective angiography was performed for location of the renal veins.The filter was centrally deployed and normally oriented.There were no complications.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 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.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implant.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization, 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 lead to explant problems after as short a period as 12 days.Clinical factors that may have influenced the event include patient and/or vessel characteristics.Without procedural films or images for review the reported event(s) could not be confirmed or further clarified.Chest pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.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 in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to embedment of the filter which is unable to be retrieved.As a direct and proximate result of these malfunctions, 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.Per the implant records, the patient was status post-left tibial/tibia fibula fracture with leg swelling and bilateral pulmonary emboli (pe) confirmed by computed tomography angiography (cta) as well as duplex evidence of left lower extremity deep vein thrombosis (dvt); therefore, placement of the filter was indicated.Under sterile conditions, using ultrasound imaging and local anesthetic, a sheath was placed percutaneously in the right common femoral vein and an inferior vena cavogram was performed.The renal veins were not demonstrated; therefore, selective right and selective left renal venography was performed.A removable optease inferior vena cava (ivc) filter was placed with its distal tip at the bottom of l1 (to the level of the renal veins).The filter was centrally deployed and normally oriented.There were no complications.According to the information received in the patient profile form (ppf), the patient reports the filter is unable to be retrieved, in addition to an unsuccessful percutaneous removal procedure attempted approximately nine months after the filter was implanted.Surgical removal procedure details were not provided.The patient further experienced chest pain and anxiety related to the filter and reports having to be on lifetime anticoagulation, becoming aware of these events approximately five years and seven months post implantation.
 
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Brand Name
466FXXXX
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014 2802
MDR Report Key10396363
MDR Text Key202736844
Report Number1016427-2020-04274
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Date Manufacturer Received09/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK 6F SHEATH; UNK COBRA CATHETER
Patient Outcome(s) Life Threatening;
Patient Age40 YR
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