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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 Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem Pulmonary Embolism (1498)
Event Date 12/14/2017
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 eleven years post filter deployment, computed tomography revealed inferior vena cava filter in the infra renal location. The tip of the filter was located approximately 4 to 4. 5 cm from the right renal vein inflow. There was an acute sub-massive pulmonary embolism. There was non-occlusive thrombus within the left pro funda femoral, femoral and popliteal veins. Approximately one year six months later, computed tomography revealed the proximal tip was located approximately 2. 4 cm below the right renal vein. The filter was tilted with the proximal tip abutting the right anterolateral wall of the inferior vena cava and the distal prongs projected slightly more towards the inferior left lateral aspect of the inferior vena cava. There was extension of tip of distal prong at the 1:30 position, approximately 6 mm beyond the wall of the inferior vena cava. Distal aspect of the prong at the 3 o¿ clock position also extended 6 mm beyond the lateral wall and abutted the right posterolateral wall of the aorta. Distal prong at the level of 4:30 position was approximately 5 mm beyond the wall of inferior vena cava and prong at the level of the 6:30 position was approximately 5. 5 mm beyond the wall of inferior vena cava. Distal tip of prong at the level of 11:30 position was approximately 4 mm beyond the wall of inferior vena cava. Therefore, the investigation is confirmed for filter tilt, filter migration and perforation of the ivc. Additionally, it can be confirmed that the patient experienced pe post deployment. However, the relationship to the filter is unknown. 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.

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient and the reason for deployment was not provided. At some time post filter deployment, it was alleged that the filter tilted and embedded in wall of the inferior vena cava. 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 Key10113752
MDR Text Key193603890
Report Number2020394-2020-03602
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 06/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF320J
Device LOT NumberGFQA2994
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/28/2006
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: 06/03/2020 Patient Sequence Number: 1
Treatment
AGGRENOX, KEFLEX, LASIX, PREDNISONE AND ZITHROMAX; AMBIEN, ALTEPLASE, ATIVAN, ENOXAPARIN AND COLACE; CIPRO, LEVAQUIN, PROTONIX, PREVACID AND UFLEX; DOCUSATE SODIUM, ATROPINE AND MORPHINE; K-DUR, HEPARIN, XANAX, DARVOCET-N AND PEPCID; LACTINEX, SENNA PLUS, RESTORIL AND BACTRIM; LIDEX, BENADRYL, PENICILLIN, FUROSEMIDE AND XYZAL; NORCO, ZOFRAN ODT, COUMADIN, LOVENOX AND TYLENOL
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