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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL; VENA CAVA FILTER Back to Search Results
Catalog Number MD800F
Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2016
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
It was reported through the litigation process that a vena cava filter was deployed successfully, after being diagnosed with pulmonary embolism.Approximately two years three months post filter deployment, inferior venogram was performed, it revealed that the filter tilted.Approximately two years ten months post filter deployment, inferior vena cava and bilateral iliac vein duplex exam was performed, it revealed that the filter migrated.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, two years three months of post deployment, filter retrieval was scheduled.Vena cavagram was performed and the filter was in standard position below the renal veins.No thrombus was identified below the filter.A loop snare was used to hook the filter, and it could not grab the filter.The filter was grabbed below the top crown and the filter was pulled up into the suprarenal position with a slight tilt.Completion venogram was done demonstrating normal vena cava above the renal.Tilted filter with no evidence of extravasation.Around six month later, inferior vena cava and bilateral iliac vein duplex exam was performed, and an inferior vena cava filter was visualized above the renal vein level with thrombus.Therefore , the investigation is confirmed for filter tilt 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: h6 (result, conclusion).H11: section a through f: the information provide by bd represents all 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 deployed successfully, after being diagnosed with pulmonary embolism.Approximately two years three months post filter deployment, inferior venogram was performed, it revealed that the filter tilted.Approximately two years ten months post filter deployment, inferior vena cava and bilateral iliac vein duplex exam was performed, it revealed that the filter migrated.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.
 
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Brand Name
MERIDIAN 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 Key10703503
MDR Text Key212072914
Report Number2020394-2020-20163
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K112497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 12/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMD800F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age66 YR
Patient Weight97
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