• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) Back to Search Results
Catalog Number 466FXXXX
Device Problem Occlusion Within Device (1423)
Patient Problems Pulmonary Embolism (1498); Death (1802); Occlusion (1984); Thrombosis (2100); Organ Dehiscence (2502)
Event Date 08/20/2014
Event Type  Death  
Manufacturer Narrative
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. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported in the legal brief (b)(6), after an unknown period of time the plaintiff subsequently developed extensive inferior vena cava filter thrombosis. Approximately 4 years after the device was implanted, the plaintiff expired due to multiple organ failure resulting from obstructive shock caused by inferior vena cava filter thrombosis. An additional legal brief indicates the filter subsequently malfunctioned and caused great bodily harm to the plaintiff including, but not limited to, caval thrombosis, pe, and dvt. As direct and proximate results of these filter malfunctions, the plaintiff suffered fatal injuries, damages, and untimely death on or about (b)(6) 2014.
 
Manufacturer Narrative
As reported in the legal brief, after an unknown period of time following implantation of an optease filter, the plaintiff subsequently developed extensive inferior vena cava filter thrombosis. Approximately 4 years after the device was implanted, the plaintiff expired due to multiple organ failure resulting from obstructive shock caused by inferior vena cava filter thrombosis. An additional legal brief indicates the filter subsequently malfunctioned and caused great bodily harm to the plaintiff including, but not limited to, caval thrombosis, pe, and dvt. As direct and proximate results of these filter malfunctions, the plaintiff suffered fatal injuries, damages, and untimely death on or about (b)(6) 2014. 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. Pulmonary embolism, deep vein thrombosis and vena cava thrombus do not represent a device malfunction. Factors that may have influenced the event include patient, pharmacological and lesion characteristics. Large thrombus within the vena cava or lower extremities may impede perfusion contributing to organ dysfunction. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN OPTEASE VENA CAVA FILTER
Type of DeviceTHROMBECTOMY SYSTEMS (DTK)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL
Manufacturer Contact
cecil navajas
circuito interior norte #1820
juarez chihuahua 32580
MX   32580
7863133880
MDR Report Key5698643
MDR Text Key46539351
Report Number9616099-2016-00324
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/06/2016
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/03/2016 Patient Sequence Number: 1
-
-