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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER THROMBECTOMY SYSTEMS

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CORDIS CASHEL OPTEASE RETRIEVAL FILTER THROMBECTOMY SYSTEMS Back to Search Results
Model Number 466F220A
Device Problem Fracture (1260)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Perforation (2001)
Event Date 05/24/2016
Event Type  Death  
Manufacturer Narrative
As reported, the patient underwent placement of an optease vena cava filter which subsequently malfunctioned and caused great bodily harm to the patient, including, but not limited to, fracture and perforation of the filter through the inferior vena cava (ivc), directly and proximately causing loss of blood from the ivc, formation of a large retroperitoneal hematoma, and death. As direct and proximate results of these filter malfunctions, the patient suffered fatal injuries, damages, and untimely death. 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 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 medical records or procedural films available for review, the reported filter fracture and perforation 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 and migration of fractured struts could not be confirmed and the exact cause could not be determined. A clinical factor contributing to the migration could not be determined. The brief also reported perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event. Without procedural films for review, the reported ivc perforation could not be confirmed and the exact cause could not be determined. The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters. Due to the placement of the filter, just below the renal veins, if a perforation of the ivc does occur, there is a possibility of blood to pool in the retroperitoneal space. The clinical presentation of this occurrence may vary, thus leading to a lengthy time until diagnosis and treatment. 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.
 
Manufacturer Narrative
Additional information was provided and is available in: (age at the time of event, date of birth), (event date), (event description), (relevant medical history), (brand name), (model, catalog, lot number, and udi number), (concomitant medical products), 6f sheath; wire, (date received by the manufacturer), (manufacturing date), (b)(4). The implant date was confirmed to be accurate. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported in the legal brief, the patient underwent placement of an optease vena cava filter which subsequently malfunctioned and caused great bodily harm to the patient, including, but not limited to, fracture and perforation of the filter through the ivc, directly and proximately causing loss of blood from the ivc, formation of a large retroperitoneal hematoma, and death. As direct and proximate results of these filter malfunctions, the patient suffered fatal injuries, damages, and untimely death. The following additional information was received per the patient¿s implant records: the patient had a history of bilateral pulmonary emboli and subdural hematoma, hypertension, depression, alcohol abuse, high cholesterol, gout. The filter was deployed for the renal vein inflow seen to l1. The patient tolerated he procedure well and there were no immediate complications. The day after implant, the patient had a temperature of 102f and experienced tachycardia with tachypnea. The patient was treated with acetaminophen. According to the information received in the patient profile form (ppf), the patient reports fracture, perforation of filter strut(s) into organs, blood clots, clotting, and/or occlusion of the ivc.
 
Manufacturer Narrative
(b)(4). Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available. If obtained, a follow up report will be submitted within 30 days upon receipt. The product remains implanted and is thus not available for analysis. A review of the manufacturing records could not be conducted without a lot number. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported in the legal brief, the patient underwent placement of an optease vena cava filter which subsequently malfunctioned and caused great bodily harm to the patient, including, but not limited to, fracture and perforation of the filter through the ivc, directly and proximately causing loss of blood from the ivc, formation of a large retroperitoneal hematoma, and death. As direct and proximate results of these filter malfunctions, the patient suffered fatal injuries, damages, and untimely death.
 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceTHROMBECTOMY SYSTEMS
Manufacturer (Section D)
CORDIS CASHEL
cahir road
co. tipperary
cashel
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
co. tipperary
cashel
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7135578
MDR Text Key106065995
Report Number1016427-2017-00886
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466F220A
Device Catalogue Number466F220A
Device Lot NumberR0707345
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/01/2017
Event Location No Information
Date Manufacturer Received07/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2007
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: 12/20/2017 Patient Sequence Number: 1
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