FDA Adverse Event Summary report: N

OPTEASE VENA CAVA FILTER

MDR report key: 1242099 · Received November 17, 2008

Report

Report Number
1242099
Date Received
November 17, 2008
Date of Event
August 1, 2008
Report Date
November 12, 2008
Manufacturer
CORDIS ENDOVASCULAR CORPORATION
Product Code
DTK
Report Source
User Facility report
Reporter Location
MN, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THE PATIENT WAS DIAGNOSED WITH DEEP VENOUS THROMBOSIS (DVT) AND HAD AN INFRARENAL OPTEASE INFERIOR VENA CAVA(IVC) FILTER PLACED ABOVE THE DVT. IT WAS RECOMMENDED THAT THE FILTER BE CHANGED IN A COUPLE OF WEEKS. ELEVEN DAYS POST IMPLANTATION, THE FILTER WAS REMOVED WITHOUT COMPLICATIONS. A VENOGRAM DONE THAT DAY DETECTED A CLOT MEASURING ABOUT 25MM ON THE FILTER AND A SUCTION THROMBECTOMY WAS DONE. THE POSSIBILITY OF ADDITIONAL CLOTS CONFIRMED THE NEED TO REPLACE THIS FILTER WITH A NEW OPTEASE IVC FILTER. INTERVENTIONAL RADIOLOGIST INDICATED THAT "IF DESIRED, THIS FILTER SHOULD BE CHANGED OR REMOVED IN 14 DAYS." AN ATTEMPT WAS MADE TO RETRIEVE THE FILTER 14 DAYS POST IMPLANTATION; HOWEVER, THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS HIGHER THAN DESIRED TO GO FORWARD WITH THE RETRIEVAL AND THE PROCEDURE WAS CANCELLED. ANOTHER ATTEMPT WAS MADE 17 DAYS POST IMPLANTATION, BUT ATTEMPTS TO SNARE/HOOK THE FILTER WERE UNSUCCESSFUL AND THE PROCEDURE WAS TERMINATED. IT WAS DECIDED TO MAKE ANOTHER ATTEMPT TO RETRIEVE THE FILTER IN ONE WEEK. TWENTY FOUR DAYS POST IMPLANTATION, ATTEMPTS WERE MADE TO SNARE THE HOOK ON THE OPTEASE FILTER. THESE ATTEMPTS WERE UNSUCCESSFUL DESPITE USING BALLOONS TO TRY AND CHANGE THE POSITION OF THE FILTER. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO IMMEDIATE COMPLICATIONS. THE RISKS AND BENEFITS OF THE PROCEDURE WERE EXPLAINED TO/ACCEPTED BY THE PATIENT/FAMILY PRIOR TO EACH OF THE PROCEDURES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 OPTEASE VENA CAVA FILTER FILTER, VENA CAVA DTK CORDIS ENDOVASCULAR CORPORATION * R0408453

Patients

Seq Age Sex Outcome Treatment
1 18 YR