• 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. RECOVERY FILTER SYSTEM 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. RECOVERY FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Foreign Body In Patient (2687)
Event Date 12/05/2012
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. Bard recovery filter was placed at the level of l2-l3 just below the renal veins for a patient with deep vein thrombosis. Approximately six years and seven months of post deployment, a computed tomography renal study was performed for right flank pain. The study showed that infrarenal inferior vena cava filter was noted. Several of the filter struts have perforated the caval wall and extend into the retroperitoneum. Two of which are within 2 mm of the aorta. A fractured strut has been completely extruded into the pre-aortic retroperitoneum. No retroperitoneal hemorrhage was noted. Around four years and one month later, a computed tomography renal study was performed which showed stable appearing inferior vena cava filter with extruded struts. Around one year and five months later, patient presented for second opinion for the filter abnormality and intermittent right lower quadrant abdominal pain. Reviewed radiological studies and advised removal of the inferior vena cava filter. Around one year and eight months later, patient presented with the diagnosis of malpositioned and fractured inferior vena cava filter. Patient was recommended for filter retrieval attempts with advanced techniques. Around nine days later, patient was planned for filter retrieval. Through the right internal jugular vein approach, a sheath was placed. The filter was grasped with endobronchial forceps and retrieved with the sheath. One tine which had already fractured and migrated into the retroperitoneum and away from the inferior vena cava was known not able to be retrieved prior to planning the procedure. Filter was inspected and was otherwise intact. Therefore, the investigation is confirmed for filter limb detachment, perforation of inferior vena cava (ivc) and filter malposition. 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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient for lower extremity venous thrombosis with contradiction to anticoagulation therapy. At some time post filter deployment, it was alleged that the filter struts detached. The device has not been removed and there were no reported attempts made to retrieve the filter. The current status of the patient is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRECOVERY FILTER SYSTEM
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 Key12164885
MDR Text Key261438418
Report Number2020394-2021-80564
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031328
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 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF048F
Device Lot NumberGFPD4715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
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: 07/14/2021 Patient Sequence Number: 1
Treatment
ASPIRIN AND HYDROCODONE-ACETAMINOPHEN; DICLOFENAC AND ESOMEPRAZOLE; OMEPRAZOLE AND ALBUTEROL
-
-