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

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER

  • 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
 

BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number EC500F
Device Problems Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2011
Event Type  malfunction  
Manufacturer Narrative
No medical images have been made available to the manufacturer. As the lot number for the device was not provided, a review of the device history records could not be performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. Medical records received and reviewed. The patient had a prophylactic inferior vena cava filter deployed via the femoral vein for multiple trauma and anticoagulation contraindication. Under intravenous ultrasound guidance, the ivc filter was deployed in usual fashion immediately below what was believed to be the left renal vein. Hemostasis was obtained. One day post filter deployment, a review of plain films demonstrated that the vena cava filter was within the right external iliac vein and not within the inferior vena cava as intended. A second femoral inferior vena cava filter was deployed within the common iliac vein with the tip of the filter at the bifurcation of the inferior vena cava. There was no reported consequence or impact to the patient. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported a prophylactic inferior vena cava filter was deployed successfully via the femoral vein using intravascular ultrasound guidance. One day post filter deployment, a review of plain films demonstrated that the vena cava filter was unintentionally deployed within the right external iliac vein and not within the inferior vena cava as originally intended. A second prophylactic inferior vena cava filter was deployed within the left common iliac vein. There was no reported consequence or impact to the patient.
 
Manufacturer Narrative
A manufacturing review could not be conducted as the lot number was not provided. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: a manufacturing review was not performed as the lot number was not provided. Neither the device nor images were returned. Medical records were provided. The medical records allege intravascular ultrasound was used to deploy a filter in what was believed to be the ivc, just below the left renal vein. Postoperatively, imaging allegedly demonstrated that the filter was not in the vena cava, but rather in the right external iliac vein. Based on the medical record review, positioning issue can be confirmed. Per the reported details, the filter was deployed using ultrasound. Per the instructions for use (ifu), the filter should be deployed using fluoroscopy. Therefore, the likely root cause for the event is user related. Labeling review: the current ifu (instructions for use) states: indications for use: the eclipse filter - femoral is indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations: contraindications for use caution: if the ivc diameter exceeds 28 mm, the filter must not be inserted into the ivc. Patients with an ivc diameter larger than 28 mm. Warnings: never advance the guidewire or introducer sheath/dilator or deploy the filter without fluoroscopic guidance. Precautions: position the retrieval hook 1 cm below the lowest renal vein. Venacavography must always be performed to confirm proper implant site. Radiographs without contrast, which do not clearly show the wall of the ivc, may be misleading. If misplacement, sub-optimal placement, or tilting of the filter occurs, consider immediate removal. Do not attempt to reposition the filter. The introducer sheath has a radiopaque distal tip to assist in visualization and predeployment filter positioning. The radiopaque distal tip on the introducer sheath, when used in conjunction with the radiopacity of the pusher wire spline, provides a "target" location between which the filter should be positioned just prior to unsheathing and deployment. Directions for use: remove the guidewire and perform a standard inferior venacavogram in both the ap and lateral view, (typically 30 ml of contrast medium at 15ml/s) through the dilator. Check for caval thrombi, position of renal veins, and congenital anomalies. Select the optimum level for filter placement and measure the ivc diameter, correcting for magnification (typically 20 percent). The black indicator mark on the pusher wire provides a visual cue indicating that the filter is approaching the end of the sheath as the mark comes adjacent to the proximal end of the touhy-borst adaptor. Prior to deployment, the exact location of the filter within the sheath should be verified under fluoroscopy. Under fluoroscopic guidance, withdraw the pusher wire back into the storage tube by firmly holding the y-adapter, storage tube, and introducer sheath assembly and pulling back on the pusher wire. Do not twist the pusher wire handle at anytime during this procedure. Follow-up venacavogram: a follow-up venacavogram may be performed after withdrawing the introducer sheath into the iliac vein (typically 30ml of contrast medium at 15ml/s).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameECLIPSE FILTER SYSTEM - FEMORAL
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 west 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1625 west 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5488211
MDR Text Key40261959
Report Number2020394-2016-00255
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEC500F
Device Lot NumberUNKNOWN
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 Received04/14/2016
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? No
Type of Device Usage Initial

-
-