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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. UNKNOWN VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN FILTER
Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Extrusion (2934); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692)
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 instruction for use (ifu) is adequate for the reported device/patient 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. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

 
Event Description

It was reported that approximately 7 years post-deployment of a vena cava filter, the filter allegedly perforated the inferior vena cava (ivc) wall. It was further reported that the patient allegedly has severe leg pain, swelling, abdominal pain and trouble breathing.

 
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Brand NameUNKNOWN VENA CAVA 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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7576167
MDR Text Key110456445
Report Number2020394-2018-00811
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN FILTER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2018
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: 06/06/2018 Patient Sequence Number: 1
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