• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SNF/SL VENA CAVA FILTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. SNF/SL VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN SNF
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Death (1802); Thrombosis (2100)
Event Type  Death  
Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. Journal article citation: poletti, p. A. , becker, c. D. , prina, l. , ruijs, p. , bounameaux, h. , didier, d. , terrier, f. (1998). Long-term results of the simon nitinol inferior vena cava filter. European radiology, 8(2), 289¿294. Doi: 10. 1007/s003300050382.
 
Event Description
It was reported in an article from the journal of european radiology titled " long-term results of the simon nitinol inferior vena cava filter " that after the filter placement, 6 patients died due to postoperative hemorrhage and 2 patients died due to pulmonary embolism, thrombosis of the inferior vena cava and both lower limbs following the introduction of the filter. One additional patient died shortly after filter insertion from the sequelae of pulmonary embolism that had occurred prior to filter insertion.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSNF/SL
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 Key9517028
MDR Text Key172618887
Report Number2020394-2019-05856
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K970099
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 12/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN SNF
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2019
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: 12/24/2019 Patient Sequence Number: 1
-
-