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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); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Blood Loss (2597)
Event Date 01/15/2013
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 were not provided for review.Medical records were provided and reviewed.Approximately four months post deployment, during filter retrieval, it was noted that the head of the filter touched the right posterolateral wall of the vena cava.Multiple retrieval devices and multiple unsuccessful attempts were made to try and position the retrieval device over the head of the filter.The filter was angulated to the right and was attached to the endothelium of the vena cava.Approximately five years three months post filter deployment, a ct demonstrated an ivc filter with multiple malpositioned limbs in addition to a fractured limb.Approximately five years four months post deployment, the filter was removed with nine limbs still attached, a limb from the liver, and two detached limbs from the vena cava.Therefore, the investigation can be confirmed for filter tilt, limb detachment and retrieval difficulties.However, the investigation is inconclusive for perforation of the ivc.Per the provided medical records, the patient underwent exploratory laparotomy surgery following filter deployment.Per the ifu((instructions for use), "procedures or activities that lead to changes in intra-abdominal pressure could affect the integrity or stability of the filter." multiple retrieval devices and multiple unsuccessful attempts were made to retrieve the filter.The filter was angulated and attached to the endothelium of the vena cava.Therefore, the procedure could have affected the integrity and stability of the filter resulting in filter tilt which led to the retrieval difficulties.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: precautions: procedures or activities that lead to changes in intra-abdominal pressure could affect the integrity or stability of the filter.Warnings: filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.Movement, migration or tilt of the filter are known complications of vena cava filters.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.(expiry date: 07/2014); (manufacturing date: 07/2011).(b)(4).
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that filter limbs perforated into organs and detached.Allegedly the filter tilted sideways and the device was unable to be retrieved.The device and filter limb(s) were removed open abdominal procedure after a previously attempted but unsuccessful percutaneous removal procedure.The patient experienced chronic abdominal pain.However, the current status of the patient is unknown.
 
Manufacturer Narrative
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.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.Approximately four months post deployment, during filter retrieval, it was noted that the head of the filter touched the right posterolateral wall of the vena cava.Multiple retrieval devices and multiple unsuccessful attempts were made to try and position the retrieval device over the head of the filter.The filter was angulated to the right and was attached to the endothelium of the vena cava.Approximately five years three months post filter deployment, a ct demonstrated an ivc filter with multiple malpositioned limbs in addition to a fractured limb.Approximately five years four months post deployment, the filter was removed with nine limbs still attached, a limb from the liver, and two detached limbs from the vena cava.Therefore, the investigation can be confirmed for filter tilt, limb detachment and retrieval difficulties.However, the investigation is inconclusive for perforation of the ivc.Per the provided medical records, the patient underwent exploratory laparotomy surgery following filter deployment.Per the ifu (instructions for use), "procedures or activities that lead to changes in intra-abdominal pressure could affect the integrity or stability of the filter." multiple retrieval devices and multiple unsuccessful attempts were made to retrieve the filter.The filter was angulated and attached to the endothelium of the vena cava.Therefore, the procedure could have affected the integrity and stability of the filter resulting in filter tilt which led to the retrieval difficulties.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: the current ifu (instructions for use) states: precautions: procedures or activities that lead to changes in intra-abdominal pressure could affect the integrity or stability of the filter.Warnings: filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.Movement, migration or tilt of the filter are known complications of vena cava filters.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.(expiry date: 07/2014) and (device: 1528).
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that filter limbs perforated into organs and detached.Allegedly the filter tilted sideways and the device was unable to be retrieved.The device and filter limb(s) were removed open abdominal procedure after a previously attempted but unsuccessful percutaneous removal procedure.The patient experienced chronic abdominal pain.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 Key8449472
MDR Text Key139755424
Report Number2020394-2019-00201
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 07/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEC500F
Device Lot NumberGFVF2226
Was Device Available for Evaluation? No
Date Manufacturer Received06/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AMOXICILLIN-CLAVULANATE, ASPIRIN,; AMOXICILLIN-CLAVULANATE, ASPIRIN,; BENEFIBER, HYCOMINE COMPOUND,; BENEFIBER, HYCOMINE COMPOUND,; LISINOPRIL, SENNA-DOCUSATE,; LISINOPRIL, SENNA-DOCUSATE,; TRIAMCINOLONE ACETONIDE; TRIAMCINOLONE ACETONIDE; AMOXICILLIN-CLAVULANATE, ASPIRIN,; BENEFIBER, HYCOMINE COMPOUND,; LISINOPRIL, SENNA-DOCUSATE,; TRIAMCINOLONE ACETONIDE
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age61 YR
Patient Weight57
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