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U.S. Department of Health and Human Services

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

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CORDIS CASHEL 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466FXXXX
Device Problems Filter (816); Defective Component (2292); Unintended Movement (3026)
Patient Problem Death (1802)
Event Date 06/01/2017
Event Type  Death  
Manufacturer Narrative

As reported, the patient underwent placement of defendants' optease filter on or about (b)(6) 2004, in (b)(6). The filter subsequently malfunctioned and caused injuries and damages to the patient, including, but not limited to, inferior vena cava (ivc) breakage, inferior vena cava (ivc) migration and complications and even death related to the filter migration. As a direct and proximate result of these malfunctions, the patient suffered life-ending injuries and damages, and required extensive medical care and treatment prior to her death. As a further proximate result, the patient suffered and died, causing significant medical expenses, 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.   without images or procedural films for review, the reported filter migration could not be confirmed and the exact cause could not be determined. Giving the limited information available at this time, clinical factor contributing to the migration could not be determined. 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. The brief also reported perforation of the ivc and death; however, a clinical conclusion could not be determined as to the cause of the event. It is unknown if the migration contributed to the reported perforation. A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters. 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/or 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 patient underwent placement of defendants' optease filter on or about (b)(6) 2004, in (b)(6). The filter subsequently malfunctioned and caused injuries and damages to the patient, including, but not limited to, inferior vena cava (ivc) breakage, inferior vena cava (ivc) migration and complications and even death related to the filter migration. As a direct and proximate result of these malfunctions, the patient suffered life-ending injuries and damages, and required extensive medical care and treatment prior to her death. As a further proximate result, the patient suffered and died, causing significant medical expenses, pain and suffering, and other damages.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter on or about (b)(6) 2004. Per the patient profile form (ppf), the filter was implanted due to a history of cervical cancer, deep vein thrombosis, bilateral pulmonary embolus, with subarachnoid hemorrhage contraindicating anticoagulation. The filter subsequently malfunctioned and caused injuries and damages to the patient, including, but not limited to, inferior vena cava (ivc) migration and complications and even death related to the filter migration. As a direct and proximate result of these malfunctions, the patient suffered life-ending injuries and damages, and required extensive medical care and treatment prior to her death. As a further proximate result, the patient suffered and died, causing significant medical expenses, pain and suffering, and other damages. The patient is reported to have undergone an open abdominal procedure to remove the filter approximately 12 years after it was placed. The patient is reported to have experienced abscess, pain, and kidney stopped functioning resulting in renal disease. The death certificate lists end stage renal disease as the cause of death. The filter remains implanted; thus, unavailable for analysis. 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. 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 is unknown if the migration event contributed to the renal disease reported. Renal disease can be related to altered blood flow into and out of the kidney structures, hypertension, iv contract infusion or structural changes of unknown etiology. Without procedural images for review and/or medical records for review regarding the kidney disease etiology or the filter removal procedure, it is not possible to accurately assess the contributing factors or root causes for the renal failure and subsequent removal of the kidney. Clinical factors that may have influenced the event include patient 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.

 
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Brand Name466FXXXX
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 Key6663822
MDR Text Key78290712
Report Number1016427-2017-00397
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberUNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue Number466FXXXX
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 Received02/19/2018
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: 06/23/2017 Patient Sequence Number: 1
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