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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL OPTEASE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problems Fracture (1260); Unintended Movement (3026)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Perforation of Vessels (2135)
Event Date 11/27/2017
Event Type  Injury  
Manufacturer Narrative
As reported, the patient underwent placement of the optease inferior vena cava (ivc) filter. Per the medical records, the patient has a history of recurrent pulmonary embolism. The filter was deployed without difficulty in the correct position and aligned. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture, embedment of the filter to the wall of the ivc, migration, and multiple perforations of the ivc wall. According to the patient profile form (ppf), the patient experienced pain in the back, legs and chest. The filter remains implanted; thus, unavailable for analysis. The product was not returned for analysis. The lot number provided was not a valid cordis lot number; therefore, no 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. The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters. Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut. Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such. Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error. Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter. Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters. It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event. A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters. Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place. Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation. 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. Pain 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. Should additional information become available, the file will be updated accordingly.
 
Manufacturer Narrative
Additional information received per the medical records indicate that the patient has a history of recurrent pulmonary embolism. The filter was deployed without difficulty in the correct position and the filter was aligned. According to the patient profile form (ppf) the patient experienced pain in the back, legs and chest. Additional information is pending and will be submitted within 30 days of receipt.
 
Manufacturer Narrative
The exact implant date is unknown. The catalog number is unknown, if received it will be provided. Complaint conclusion: as reported, 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, fracture, embedment of the filter to the wall of the ivc, migration, and multiple perforations of the inferior vena cava (ivc) wall. 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, and pain and suffering, and other damages. The product was not returned for analysis. Additionally, as the sterile lot number was not available, device history record review could not 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. Without images or procedural films for review, the reported filter fracture, migration and perforation of the ivc wall could not be confirmed and the exact cause could not be determined. The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters. Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut. Inferior vena cava (ivc) filter migration is also a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such. Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error. Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter. Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters. The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters. The legal brief also noted that the filter was embedded in the wall of the ivc. Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days. 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 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, fracture, embedment of the filter to the wall of the ivc, migration, and multiple perforations of the ivc wall. 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, and pain and suffering, and other damages.
 
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Brand NameOPTEASE VENA CAVA FILTER
Type of DeviceFILTER, 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 Key7130208
MDR Text Key263928217
Report Number1016427-2017-00885
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
Device Lot Number17279886
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2019
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 Treatment Data
Date Received: 12/19/2017 Patient Sequence Number: 1
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