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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 Migration or Expulsion of Device (1395); Extrusion (2934); Positioning Problem (3009); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); No Consequences Or Impact To Patient (2199)
Event Date 10/30/2010
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for perforation of the ivc 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: 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.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 approximately seven years post filter deployment, a ct scan demonstrated filter perforation of the ivc.The filter was removed successfully.The current patient status is unknown.
 
Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for perforation of the ivc 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.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 approximately seven years post filter deployment, a ct scan demonstrated filter perforation of the ivc.The filter was removed.The current patient status is unknown.
 
Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: b5,b7,d4(expiry date: 08/2013),g3,g4.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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.Approximately seven years post filter deployment allegedly a computed tomography scan demonstrated that the filter struts perforated the inferior vena cava.The device was removed percutaneously.The patient experienced stabbing pain in abdominal area; however, the current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.The filter was deployed with minimal tilt and the legs were deployed completely.Approximately six years and ten months post filter deployment, computed tomography revealed inferior vena cava filter with some prongs extended through the wall of the inferior vena cava.Approximately one month later, computed tomography revealed most of the struts of the filter had penetrated and crossed the boundaries of the infra renal vena cava.There were 2 struts that seem to be penetrating the 3rd/4th portion of the duodenum.Approximately a few days later, patient presented with epigastric abdominal pain and currently to undergo vena cava filter retrieval.There was a concern for possible gi complications as the filter has migrated.Then retrieval procedure was performed through right internal jugular vein access.The filter was retrieved successfully.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter migration and positioning issue.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.H10: (expiry date: 08/2013).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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.Approximately seven years post filter deployment , a computed tomography scan demonstrated that the filter struts perforated the inferior vena cava.The device was removed percutaneously.The patient experienced stabbing pain in abdominal area; however, the current status of the patient is unknown.
 
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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 Key7656781
MDR Text Key113003113
Report Number2020394-2018-01059
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,Followup
Report Date 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEC500F
Device Lot NumberGFUG3502
Was Device Available for Evaluation? No
Date Manufacturer Received01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age62 YR
Patient Weight79
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