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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - JUGULAR; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - JUGULAR; VENA CAVA FILTER Back to Search Results
Catalog Number MD800J
Device Problems Difficult to Remove (1528); Extrusion (2934); Patient Device Interaction Problem (4001)
Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)
Event Date 05/27/2016
Event Type  Death  
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 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 some time post vena cava filter deployment filter limbs extend through the wall of the ivc, into the duodenum.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.
 
Manufacturer Narrative
Manufacturing review: a device history review (dhr) 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.Therefore, the investigation is inconclusive for the alleged 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.
 
Event Description
It was reported through the litigation process that some time post vena cava filter deployment filter limbs extend through the wall of the ivc, into the duodenum.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.New information: 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.At some time post filter deployment, it was alleged that the filter struts perforated into organs.The device was removed percutaneously.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: 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 provided and reviewed.Approximately two years and eleven months later, a computed tomography (ct) abdomen and pelvis with contrast was performed and it revealed that the legs of the filter extend through the wall of the inferior vena cava and appear to extend into the adjacent mucosa of the dorsal aspect of the fourth portion of the duodenum.One of the filter legs extends within 2-3mm of the aorta.After six months, the patient scheduled for the filter retrieval; the right internal jugular vein was accessed.An ensnare loop snare was attempted first but the hook could not be engaged.Therefore, then endobronchial forceps were used to free the tip.Then, an ensnare was used to secure the hook on the filter and traction on the snare used to collapse the filter into the 12 french sheath.Filter was removed and then send to pathology.The patient was reportedly expired but the cause of death and date of death was not provided in the medical record.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava and retrieval difficulties.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: b5,g3,g4.H11: b1,d1,d4(product catalog number),h1,h6(patient, result).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.At some time post filter deployment, it was alleged that the filter struts perforated the wall of the inferior vena cava, into the duodenum.The device was removed percutaneously.The patient reportedly expired.
 
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Brand Name
MERIDIAN FILTER SYSTEM - JUGULAR
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7545395
MDR Text Key109315701
Report Number2020394-2018-00729
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K102511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup
Report Date 01/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMD800J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
KLONOPIN, SAPHRIS, PAXIL, ZOLOFT, CELEXA; LEXAPRO, EFFEXOR, CYMBALTA AND WELLBUTRIN
Patient Outcome(s) Death;
Patient Age40 YR
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