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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 Problem Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 07/17/2017
Event Type  Injury  
Manufacturer Narrative

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. Post filter deployment, patient presented with abdominal pain. Subsequently a computed tomography revealed an inferior vena cava filter in place. Filter tip was located 1. 3 cm below the level of the lowest left renal vein. The apex of the filter was approximately 2 mm from the anterior aspect of the inferior vena cava filter wall. Multiple filter struts or limbs perforated beyond the inferior vena cava wall. The maximum length of the filter limb perforation beyond the inferior vena cava filter wall was 1. 6 cm. Inferior vena cava filter limbs extended into the wall of the adjacent aorta, l3 vertebral body, duodenum, and retroperitoneum. Therefore, the investigation is confirmed for the perforation of the ivc. Based on 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 a vena cava filter was deployed successfully, the reason for the filter deployment was not provided. At some time, post filter deployment, it was alleged that the filter struts perforated. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient reportedly experienced abdominal pain; however, 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 NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10319101
MDR Text Key200203716
Report Number2020394-2020-05084
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
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 07/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received07/01/2020
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: 07/24/2020 Patient Sequence Number: 1
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