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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL; VENA CAVA FILTER Back to Search Results
Catalog Number EC500F
Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001); Migration (4003)
Patient Problem Pain (1994)
Event Date 05/16/2018
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive for the alleged perforation of the ivc, filter limb detachment and filter tilt as no objective evidence has been provided to confirm alleged deficiency with the filter.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.
 
Event Description
It was reported through the litigation process that the filter tilted, perforated and struts detached.The detached filter strut retained in hepatic dome, right lung base.The patient reportedly experienced pain; however, the current status of the patient is unknown.
 
Event Description
It was reported through the litigation process that the filter tilted, perforated and struts detached.The detached filter strut retained in hepatic dome, right lung base.The patient reportedly experienced pain; however, the current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately five years and three months of post deployment, the patient presented for filter removal, computed tomography venogram of abdomen and pelvis revealed tilted/transversely oriented filter, at the level of l3-l4, with legs extended beyond the margin of the inferior vena cava.Ultrasound guidance and a 5 french micro-puncture set were used to access the right internal jugular vein.An 0.035 x 145 cm bentson wire was inserted and advanced into the inferior vena cava.A 5 french x 70 cm pigtail was advanced over the wire and used for cavagram, which revealed no thrombus in the cava or on the filter.Ultrasound guidance and a 19g needle were used to access the right common femoral vein.An 0.035 bentson wire was inserted and advanced into the inferior vena cava.A 5f x 10 cm vascular sheath was placed.The bentson in the right internal jugular vein was then exchanged for a 0.035 x 180 cm amplatzer wire and the pigtail catheter removed.Serial dilation was performed over the wire under fluoroscopy and then the 16 french x 45 cm check-flo performer introducer sheath was inserted under fluoroscopy.Endobronchial forceps were then used to grasp the filter and pull it out through the sheath.Two struts remained in the inferior vena cava and were subsequently removed using the forceps.Repeat cavagram revealed no extravasation or thrombus.A 5 french x 100 cm cobra catheter was then advanced from below and selective venograms of the hepatic veins were performed to better assess the location of the fractured strut that appears to either be in the hepatic dome or right lung base.Inspection of the filter shows that all the struts but 1 were removed.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc), filter tilt, filter limb detachment and filter migration.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.H11:section a through f - the information provided by bd 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 bd.
 
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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 Key10424754
MDR Text Key203461203
Report Number2020394-2020-05477
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
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEC500F
Device Lot NumberGFWG2936
Was Device Available for Evaluation? No
Date Manufacturer Received05/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age41 YR
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