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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466FXXXX
Device Problems Fracture (1260); Unintended Movement (3026)
Patient Problems Perforation of Vessels (2135); Stenosis (2263)
Event Date 09/29/2020
Event Type  Injury  
Manufacturer Narrative

Occupation: other, senior counsel, litigation please note that the exact event date is unknown and the event date is the complaint awareness date. As reported, the patient underwent placement of an optease retrievable vena cava filter. The patient is reported to have had a history of multiple traumas. The indication for the filter placement was not reported. The filter was implanted via the right internal jugular vein and placed in an infrarenal position. Approximately sixteen years after the filter implantation, the patient became aware that the filter had tilted and fractured and was associated with stenosis. In addition, filter struts had perforated outside the inferior vena cava (ivc). The patient further reported having experienced rhabdomyolysis, necrotizing myopathy autoimmune disease and chest pain associated with the filter. 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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the ivc 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. Without images or procedural films for review, the reported filter tilt, fracture and ivc perforation events could not be confirmed and the exact cause could not be determined. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness. Additionally, the timing and mechanism of the filter tilt is unknown. The timing and mechanism of the fracture has not been reported at this time. The instructions for use (ifu) states that 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. It is unknown if the tilt contributed to the reported perforation. A review of the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters. 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. Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction. A protective filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive). Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli. Due to the nature of the complaint, the reported rhabdomyolysis, necrotizing myopathy and chest pain experienced by the patient could not be confirmed and the exact cause could not be determined. These clinical events do not represent evidence of a device malfunction. Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics. Given the limited information available for review, there is nothing to suggest that a malfunction in 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. Please note that this is the initial report for this product.

 
Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter. The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to filter facture, perforation, tilt and stenosis. 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. Additional information received per the medical records indicate that the patient had a history of multiple trauma. The filter was deployed via the patient's right internal jugular. It was placed with the filter tip just below the renal veins. Post implant images reveal the filter to be in a good position.   additional information received per the patient profile form (ppf) states that the patient experienced fracture, perforation of filter struts outside the inferior vena cava (ivc) and tilt. The patient became aware of the reported events approximately sixteen years and after the index procedure. The patient reported that she also experienced rhabdomyolysis, necrotizing myopathy autoimmune disease and chest pain related to the filter.

 
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Brand NameUNKNOWN OPTEASE VENA CAVA FILTER
Type of DeviceFILTER, 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 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key12372361
MDR Text Key268297450
Report Number1016427-2021-05339
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/26/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number466FXXXX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/26/2021 Patient Sequence Number: 1
Treatment
UNKNOWN SHEATH
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