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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN G2
Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/16/2018
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown. Investigation summary: the device was not returned for evaluation. Medical records were not provided. The investigation is inconclusive for the alleged filter tilt, filter migration, filter limb detachment and perforation of the inferior vena cava as no objective evidence has been provided to confirm any alleged deficiency with the filter. A definitive root cause for the alleged filter tilt, filter migration, filter limb detachment and perforation of the inferior vena cava could not be determined based upon the provided 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.
 
Event Description
It was reported through the litigation process that approximately ten years and four months post filter deployment, it was alleged the filter tilted, migrated, detached, and struts perforated through the inferior vena cava wall with one strut extending to the wall of the aorta. The current status of the patient is unknown.
 
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Brand NameG2 FILTER SYSTEM
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 12804
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12015225
MDR Text Key256785653
Report Number2020394-2021-01221
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 06/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN G2
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/17/2021 Patient Sequence Number: 1
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