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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 Problem Patient-Device Incompatibility (2682)
Patient Problem Bowel Perforation (2668)
Event Date 03/01/2021
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 09/2012.
 
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.After some time post filter deployment, it was alleged that the filter struts perforated.The device has been removed percutaneously.The patient had surgery for perforated duodenum.However, the current status of the patient is unknown.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and 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.After post filter deployment, patient presents with filter caval perforation and filter legs are within the renal hilum.Recently the patient had surgery for perforated duodenum.Approximately six years and ten months later, the patient presented for filter removal, the right internal jugular vein was percutaneously accessed with a micro-puncture set.A wire was advanced under fluoroscopic guidance into the inferior vena cava.Serial dilatations were performed over the wire to accommodate placement of the filter retrieval sheath.The sheath was advanced beyond the filter into the distal and inferior vena cava.Inferior vena cava gram revealed no evidence of thrombus within the filter.Next using a goose neck snare, the retrieval hook was grasped.The sheath was then used to collapse the filter and removed in its entirety.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava (ivc).The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Expiry date: 09/2012 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.After some time post filter deployment, it was alleged that the filter struts perforated.The device has been removed percutaneously.The patient had surgery for perforated duodenum.However, 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 Key11559560
MDR Text Key241953658
Report Number2020394-2021-00655
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 05/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMD800F
Device Lot NumberGFVI0121
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/01/2021
Initial Date FDA Received03/24/2021
Supplement Dates Manufacturer Received05/14/2021
Supplement Dates FDA Received05/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age75 YR
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