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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. NITNOL FILTER VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN FILTER
Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Atrial Fibrillation (1729)
Event Date 02/09/2008
Event Type  Injury  
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: hermsen, j. L. , ibele, a. R. , faucher, l. D. , nale, j. K. , schurr, m. J. , & kudsk, k. A. (2008). Retrievable inferior vena cava filters in high-risk trauma and surgical patients: factors influencing successful removal. World journal of surgery, 32(7), 1444¿1449. Doi: 10. 1007/s00268-007-9462-z.

 
Event Description

It was reported in an article from the world journal of surgery titled " retrievable inferior vena cava filters in high-risk trauma and surgical patients: factors influencing successful removal " that 3 patients experienced nonfatal pulmonary embolism (pe) on 3,5 and 39 days after filter placement and received anticoagulation therapy. One patient experienced intractable abdominal pain as the filter strut was penetrating the duodenum, therefore, the filter was removed. One patient experienced post removal related atrial fibrillation requiring cardioversion with propafenone. The status of the patients was not provided.

 
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Brand NameNITNOL FILTER
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 Key9872236
MDR Text Key185228838
Report Number2020394-2020-01966
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 HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN FILTER
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 Received07/24/2020
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: 03/24/2020 Patient Sequence Number: 1
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