Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Extrusion (2934); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stroke/CVA (1770)
Event Date 12/11/2015
Event Type  Injury  
Manufacturer Narrative
No medical images have been made available to the manufacturer.Medical records were provided and reviewed.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: the patient presented with severe pulmonary embolisms from deep venous thrombosis and a vena cava filter was deployed in the infrarenal position.The patient tolerated the procedure well and was transferred to the recovery room in stable condition.No further information was provided regarding the current status of 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 through the litigation process that a vena cava filter was placed after being diagnosed with deep vein thrombosis/pulmonary embolism.Some time post filter deployment (date not provided), the patient allegedly experienced a middle cerebral artery stroke.Patient status was not provided.
 
Manufacturer Narrative
Manufacturing review: a manufacturing review was performed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.There was no specific deficiency alleged in the provided medical records.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: potential complications: procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.Possible complications include, but are not limited to, the following: stroke.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed after being diagnosed with deep vein thrombosis/ pulmonary embolism.Some time post filter deployment (date not provided), the patient allegedly experienced a middle cerebral artery stroke.Patient status was not provided.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed after being diagnosed with deep vein thrombosis/pulmonary embolism.Some time post filter deployment (date not provided), the patient allegedly experienced a middle cerebral artery stroke.Patient status was not provided.New information: it was reported through the litigation process that some time post filter deployment, filter strut(s) perforated into organs.The device has not been removed and there were no reported attempts made to retrieve the filter.It was further reported that the patient experienced a stroke and deep vein thrombosis; however, the status of the patient is unknown.
 
Manufacturer Narrative
A manufacturing review was performed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Medical records review: the patient with pulmonary embolisms from deep venous thrombosis (dvt) had a vena cava filter deployed in an infrarenal position.The patient tolerated the procedure well.Approximately three years and ten months post filter deployment, the patient was diagnosed with an acute right middle cerebral artery ischemic stroke.The history of present illness indicated a patient history for the past six months of left sided numbness and fainting spells.Bilateral venous duplex ultrasound demonstrated acute nonocclusive dvt in the posterior tibial and peroneal veins.A lumbar spine x-ray demonstrated the filter projecting along the right side of the l2 vertebral body.Approximately five years and one month post filter deployment, a computed tomography scan of the abdomen and pelvis demonstrated prongs of the filter extending through the wall of the inferior vena cava into adjacent retroperitoneal structures; one of the prongs abutted but did not clearly penetrate the abdominal aorta.A left lower extremity venous ultrasound demonstrated partial thrombosis of left proximal superficial femoral vein.Investigation summary: the device was not returned for evaluation.Images were not provided for review.However, medical records were provided and reviewed.Based on the medical records, the investigation can be confirmed for perforation of the ivc.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ECLIPSE FILTER SYSTEM - FEMORAL
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7125055
MDR Text Key95171213
Report Number2020394-2017-01769
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K093659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2015
Device Catalogue NumberEC500F
Device Lot NumberGFVL0176
Was Device Available for Evaluation? No
Date Manufacturer Received05/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age41 YR
Patient Weight116
-
-