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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number MD800F
Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Positioning Problem (3009)
Patient Problem Abdominal Pain (1685)
Event Date 07/22/2013
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: a lot history review was performed. This is the only complaint to date for this lot number. Therefore, a device history record review is not required. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. After filter placement a follow up cavagram was revealed the filter well apposed to the caval wall and just slightly tilted to the left but still well within the lumen. Approximately three years one month of post deployment, the patient complaints of abdominal pain a computed tomography (ct) abdomen and pelvis was revealed an inferior vena cava filter in place. Few legs appear to be terminating slightly outside of the inferior vena cava. After one year and one month the patient complaints of abdominal pain a computed tomography (ct) abdomen and pelvis was revealed an inferior vena cava filter in place, without evidence of thrombosis. Of note, several of the struts of the filter appear to extend external to the wall of the vena cava. Eventually after one month and fifteen days the patient scheduled for the filter retrieval; the right internal jugular vein was accessed. The filter was fractured. Venogram was performed which demonstrated patent inferior vena cava with multifocal penetration of the filter struts. Initially, attempt was made to isolate and remove the fractured arm fragment with forceps. However, this fragment was too close to the filter apex. Therefore, the filter apex was dissected free from the caval wall, and the main filter body was carefully sheathed taking care not to disturb the adjacent fractured fragment. The main inferior vena cava filter was removed. Subsequently, the forceps were advanced and the fractured fragment was carefully engaged, sheathed and completely removed. Therefore, the investigation is confirmed for filter positioning issue, filter limb detachment, perforation of the inferior vena cava. However, the investigation is inconclusive for filter tilt. 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. (expiry date: 01/2014), (b)(4).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before orthopedic procedure. Approximately four years and three months post filter deployment, the filter removal procedure had done and it became apparent that the filter tilted, detached within the ivc and penetrating the ivc wall. The filter and the detached struts were removed percutaneously. The current status of the patient is unknown.

 
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Brand NameMERIDIAN FILTER SYSTEM - FEMORAL
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 Key10406596
MDR Text Key202872879
Report Number2020394-2020-05380
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK112497
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 08/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberMD800F
Device LOT NumberGFWL2913
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2020
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: 08/14/2020 Patient Sequence Number: 1
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