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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM; VENA CAVA FILTER Back to Search Results
Catalog Number UNK MERIDIAN
Device Problems Obstruction of Flow (2423); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2012
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record will 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 placed in a patient after being diagnosed with deep vein thrombosis.At the time of deployment, it was alleged that the filter had positioning problem, occlusion and the filter was shrunken.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 manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.A new meridian filter was placed, released, and centered around l3.The filter did not completely release initially.This seemed to be related to likely previous thrombus in the vena cava, which had resolved.The balloon was then used to test the filter and as it was pulled proximally, the filter was engaged well in the wall and would not move.Approximately, two years six months of post deployment, computed tomography of abdomen and pelvis with contrast demonstrated an infrarenal inferior vena cava filter which was predominantly collapsed and there was no significant caval lumen.It also demonstrated an occluded inferior vena cava.After, twenty-six days, inferior venacavogram demonstrated an inferior vena cava occlusion started approximately 1 cm above the inferior vena cava filter which was fibrosed down.After, twenty-one days, it was found to have occlusion of common femoral veins to inferior vena cava with shrunken and scarred inferior vena cava filter.Around, eleven months and twenty-two days later inferior venacavogram showed that an inferior vena cava filter was in position below the left renal vein.Around, one year nine months later, inferior venacavogram showed an inferior vena cava occlusion with a shrunken inferior vena cava filter identified.Therefore, the investigation is confirmed for the material deformation, positioning problem and occlusion of the inferior vena cava (ivc).The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b6, g3, h6 (method).H11: h6 (result and 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.H3 other text : device not returned.
 
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.At the time of deployment, it was alleged that the filter had positioning problem, occlusion and the filter was shrunken.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
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key12156071
MDR Text Key261201827
Report Number2020394-2021-01307
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK MERIDIAN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/15/2021
Initial Date FDA Received07/13/2021
Supplement Dates Manufacturer Received07/19/2021
Supplement Dates FDA Received07/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MULTIVITAMINS, ZOLOFT, LASIX; MULTIVITAMINS, ZOLOFT, LASIX; SYNTHROID, FERROUS SULFATE AND TRAMADOL; SYNTHROID, FERROUS SULFATE AND TRAMADOL; ULTRAM, COUMADIN, CALCIUM; ULTRAM, COUMADIN, CALCIUM; MULTIVITAMINS, ZOLOFT, LASIX; SYNTHROID, FERROUS SULFATE AND TRAMADOL; ULTRAM, COUMADIN, CALCIUM
Patient Outcome(s) Other;
Patient Age61 YR
Patient Weight63
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