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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE FILTER; THROMBECTOMY SYSTEMS (DQO)

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CORDIS CORPORATION TRAPEASE FILTER; THROMBECTOMY SYSTEMS (DQO) Back to Search Results
Catalog Number 466P306X
Device Problem Occlusion Within Device (1423)
Patient Problem Thrombosis (2100)
Event Date 04/21/2016
Event Type  Injury  
Manufacturer Narrative
Please note that the event date is unknown but for reporting purposes the alert date of (b)(6) 2016 is being used.The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.
 
Event Description
As reported via the legal department, notification of legal action was received involving four plaintiffs.Plaintiff number one (#1) underwent placement of a trap ease permanent vena cava filter.The device subsequently malfunctioned and caused, inter alia, thrombosis of the inferior vena cava.As a result of the malfunction, the patient has suffered life-threatening injuries and damages and required extensive medical care and treatment.The plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.No additional information is available.
 
Manufacturer Narrative
As reported via the legal department, notification of legal action was received.One plaintiff underwent placement of a trapease permanent vena cava filter.The device subsequently malfunctioned and caused, inter alia, thrombosis of the inferior vena cava.As a result of the malfunction, the patient has suffered life-threatening injuries and damages and required extensive medical care and treatment.The plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.No additional information is available.The device remains implanted in the patient and is not available for inspection.Manufacturing records (dhr) could not be reviewed, as the product catalog and lot number are not available.The purpose of a vena cava filter is to catch thrombus (a clot of blood formed within a blood vessel) from the lower extremities as it travels along normal blood flow patterns up towards the heart.Thrombus in the filter does not represent a device malfunction.Thrombosis in the filter is a well-known potential complication and occurs in approximately 3.6 to 11.2% of all patients.As such, it is addressed in the product¿s instructions for use.Factors that may contribute to thrombus may include patient factors, pharmacological and lesion characteristics.Based on the limited information available for review, there is no indication of a design or manufacturing related cause for this event.Therefore, no corrective action will be taken at this time.Should additional information become available, the file will be updated accordingly.
 
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Brand Name
TRAPEASE FILTER
Type of Device
THROMBECTOMY SYSTEMS (DQO)
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 Key5651208
MDR Text Key45058779
Report Number9616099-2016-00236
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 04/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number466P306X
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/21/2016
Initial Date FDA Received05/12/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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