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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 Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 06/21/2017
Event Type  Injury  
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. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately five years and seven months of post deployment, an attempt was made to remove the cranial (bard inferior vena cava filter) and infra renal vein (cook select) inferior vena cava filters from the patient¿s body that were no longer needed. Through the ultrasound-guided right internal jugular vein access, a 5-french vascular sheath was placed. An omni flush catheter was taken to the right iliac veins. A vena cavogram showed patency of the inferior vena cava renal washout and presence of 2 inferior vena cava filters. There was a cook select infra renal vein filter and there was a suprarenal vein inferior vena cava filter, which was a bard meridian filter. The bard inferior vena cava filter in the suprarenal caval position was not tilted or stenosed. Sheath was taken to the bard meridian filter. A gooseneck snare was used to engage the filter hook. As the physician engaged the hook and collapsed the filter, it was obvious that 1 of the legs of the filter had already fractured. This appeared to be imbedded in the inferior vena cava wall. The filter was then removed and foreign body was impaled in the inferior vena cava wall, which appeared to be chronic. Next, the physician went ahead after multiple attempts to get a gooseneck snare to engage the foreign body leg of the filter. With fluoroscopic guidance, the physician carefully removed it back into the large sheath and accounted on the back table. Next, a gooseneck snare was re-attempted multiple times to engage the infra renal vein select inferior vena cava filter. Eventually, the physician was able to get the filter to pull into the sheath and remove it in its entirety on the back table. Completion venogram showed excellent results with brisk flow through the inferior vena cava. There was no significant injury, vasospasm or thrombus. Chest x-ray showed no foreign bodies. The sheath was then removed. Manual compression was held to ensure hemostasis. Therefore, the investigation is confirmed for filter limb detachment. However, the investigation is inconclusive for perforation of the inferior vena cava (ivc). 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. 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/pulmonary embolism. At some time post filter deployment, it was alleged that the filter struts detached. The device and the detached struts were removed percutaneously. The current status of the patient is unknown.

 
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Brand NameMERIDIAN FILTER SYSTEM - JUGULAR
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key12172045
MDR Text Key261650169
Report Number2020394-2021-80567
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK102511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberMD800J
Device LOT NumberGFVH4204
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/23/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/15/2021 Patient Sequence Number: 1
Treatment
FAMOTIDINE, FUROSEMIDE, LISINOPRIL AND MELOXICAM; RESTORIL, MAXZIDE AND EFFEXOR; TEMAZEPAM, DOCUSATE, TYLENOL AND OMEPRAZOLE; TIZANIDINE, VENLAFAXINE AND RISPERIDONE; TRAMADOL, OXYBUTYNIN, ELIQUIS AND DECADRON
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