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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR VENA CAVA FILTER Back to Search Results
Catalog Number RF320J
Device Problems Obstruction of Flow (2423); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)
Patient Problem Abdominal Pain (1685)
Event Date 08/23/2014
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, six years and seven months post deployment the patient was recently diagnosed with a blocked inferior vena cava filter. Around, three years and ten months later, x-ray of pelvis was performed which showed inferior vena cava filter. After, eighteen days, computed tomography of lumbar spine without contrast was performed for lumbar spinal stenosis which showed inferior vena cava filter identified at the level of l3-l4. One of the legs of this filter appears to be broken and lodged in the l3-l4 intervertebral disc. This does not affect the spinal canal. Around, sixteen days, the patient experienced abdominal pain, x-ray of abdomen was performed which revealed an inferior vena cava filter at the l3 vertebral level. On the next day, the patient experienced abdominal pain, computed tomography of abdomen and pelvis without contrast was performed which showed inferior vena cava filter terminates below the level of the renal veins. Collapsed inferior vena cava and iliac vessels upstream from the inferior vena cava filter. Therefore, the investigation is confirmed for occlusion of the inferior vena cava (ivc). However, the investigation is inconclusive for the perforation of the inferior vena cava (ivc) and filter limb detachment. 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: 10/2010).

 
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 and pulmonary embolus with gastrointestinal bleeding. At some time, post filter deployment, it was alleged that the filter occluded, struts perforated, detached, and the patient reportedly experienced abdominal pain. 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 NameG2 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 Key12342239
MDR Text Key267261488
Report Number2020394-2021-80705
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052578
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 08/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF320J
Device LOT NumberGFRI3360
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/10/2007
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: 08/19/2021 Patient Sequence Number: 1
Treatment
ATORVASTATIN, CEPHALEXIN, DOCUSATE SODIUM; COUMADIN, ACETAMINOPHEN, ALLOPURINOL, APIXABAN; DULOXETINE, FOLIC ACID, GABAPENTIN; LEVOTHYROXINE, LIDOCAINE, METOPROLOL TARTRATE; ONDANSETRON, OXYBUTYNIN, OXYCODONE, PILOCARPINE; POLYETHYLENE GLYCOL, PREDNISONE; SODIUM BICARBONATE, TORSEMIDE; SODIUM THIOSULFATE AND QUETIAPINE
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