• 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. MERIDIAN FILTER SYSTEM - FEMORAL 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. MERIDIAN FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number MD800F
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Date 04/19/2017
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. Approximately three years and two months later, a computed tomography (ct) abdomen without contrast was performed and it revealed there was an inferior vena cava filter in place. The tip/cephalad end of the filter was located 0. 5cm below the confluence of the left renal vein and inferior vena cava. The filter was tilted anteriorly, and the tip of the filter contacts the anterior wall of the inferior vena cava. The tips of the two of the posterior struts of the filter extend beyond the margin of the posterior wall of the inferior vena cava. A fat plane was visualized between these 2 limbs and the posterior wall of the inferior vena cava. This was suggestive of a chronic perforation. One of the posterior medial struts of the extends into a lumbar vein. Therefore, the investigation is confirmed for alleged filter tilt and perforation of the inferior vena cava (ivc). Based on 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: 07/2014).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism. At some time post filter deployment, it was alleged that filter tilted and struts perforated the inferior vena cava wall and lumbar vein. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient reportedly experienced abdominal and back pain, however: current status of the patient is unknown.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10342730
MDR Text Key200961348
Report Number2020394-2020-05214
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 07/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberMD800F
Device LOT NumberGFXF2753
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
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: 07/30/2020 Patient Sequence Number: 1
Treatment
LOVENOX, LEVOTHYROXINE AND COUMADIN
-
-