• 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 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 CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306AU
Device Problems Filter (816); Failure to Align (2522)
Patient Problems Coagulation Disorder (1779); Occlusion (1984)
Event Date 11/06/2018
Event Type  Injury  
Manufacturer Narrative

As reported, a patient underwent placement of a trapease inferior vena cava (ivc) filter. Per the implant records, the indication was pulmonary embolus (pe) and deep venous thrombosis (dvt). The trapease device was inserted and advanced up to the level of l2-l3 where it was deployed uneventfully. The patient tolerated the procedure well. The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to malfunction, including tilting. Per the patient profile form (ppf), the patient reports blood clots, clotting and/or occlusion of the inferior vena cava (ivc), in addition to device unable to be retrieved, and no documented attempts to remove the filter. The patient further experienced anxiety related to the filter. The product was not returned for analysis. A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. The trapease vena cava 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 procedural films for review, the filter tilt reported could not be confirmed. Additionally, the timing and mechanism of the filter tilt is unknown. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness. Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction. Anxiety does not represent a device malfunction and may be related to underlying patient related issues. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. Without procedural films or images for review the reported event(s) could not be confirmed. Given the limited information available for review at this time, there is nothing to suggest that the reported events are 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.

 
Event Description

As reported in the legal brief, a patient underwent placement of a trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to malfunction, including tilting and not retrievable that causes injury and damage to the patient. Per the implant records, the patient was reported to have a pre-implant diagnosis of pulmonary embolus (pe) and deep venous thrombosis (dvt) and underwent placement of a vena cava filter with the use of fluoroscopy. Ultrasound was used to identify the position of the right femoral vein and then the skin was anesthetized at location and an introducer needle inserted. A guidewire was then inserted through the needle and guided under fluoroscopy up to the diaphragm. The device was inserted and advanced up to the level of l2-l3 where it was deployed uneventfully. The patient tolerated the procedure well; experienced minimal blood loss, had no complications and was sent to the recovery room in satisfactory condition. According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately two years and six months after the filter implantation. The patient reports blood clots, clotting and/or occlusion of the inferior vena cava (ivc), in addition to device unable to be retrieved, and no documented attempts to remove the filter. The patient further experienced anxiety related to the filter.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRAPEASE PVCF FEM/JUG 55CM CSI
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key10161923
MDR Text Key195394465
Report Number1016427-2020-04028
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 06/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2018
Device MODEL Number466P306AU
Device Catalogue Number466P306AU
Device LOT Number17366467
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/02/2015
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: 06/17/2020 Patient Sequence Number: 1
Treatment
UNK DILATOR; UNK GUIDEWIRE; UNK INTRODUCER NEEDLE; UNK WIRE
-
-