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

MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

  • 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 CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306X
Device Problem Failure to Align (2522)
Patient Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Thrombosis (2100); No Code Available (3191)
Event Date 07/28/2017
Event Type  Injury  
Manufacturer Narrative
Complaint conclusion: as reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.At some point after the implantation, the patient became aware that the filter had tilted and was associated with a deep vein thrombosis (dvt).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 trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called dvt.A dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).This event does not represent a malfunction of the device.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Given the limited information available for review, there is nothing to suggest that a malfunction in 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.
 
Event Description
As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: dvt, filter tilt.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.
 
Manufacturer Narrative
Section b5: the filter was deployed via the patient's right femoral vein.The filter was placed just inferior to the level of the renal veins.A post procedural view demonstrated good alignment.  additional information received per the patient profile form (ppf) states that the patient experienced tilting of the filter, blood clots, clotting and or occlusion of the inferior vena cava (ivc).The form specified that the patient experienced three blood clots in the lungs, shortness of breath, problems walking and pain.The patient became aware of the reported events approximately one year and eight months after the index procedure.The patient states that stints were placed in both legs to help blood flow, scar tissue has grown over the stints which limits blood flow.Due to the stints, the right kidney stopped working and a tube was placed "in the kidney where it would work." the patient has physical therapy to assist with walking.Additionally, the patient claims that they will be disabled for life.Section h6: patient code '3191' was used for "scar tissue has grown over the stints".Additional information is pending and will be submitted within 30 days of receipt.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRAPEASE PVCF FEM/JUG 55CM CSI
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
MDR Report Key8884467
MDR Text Key154173145
Report Number1016427-2019-03162
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/20/2019
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? Yes
Device Operator Health Professional
Device Expiration Date03/31/2018
Device Model Number466P306X
Device Catalogue Number466P306AU
Device Lot Number17237648
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/18/2019
Initial Date FDA Received08/12/2019
Supplement Dates Manufacturer Received08/21/2019
Supplement Dates FDA Received09/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age68 YR
-
-