Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Problem Migration or Expulsion of Device (1395)
Patient Problem Pain (1994)
Event Date 10/27/2017
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Bard recovery filter was implanted below the renal veins for patient with large saddle pulmonary embolism and deep vein thrombosis.Approximately twelve years and one-month post filter deployment, computed tomography (ct) chest revealed partially visualized caval filter was observed in the suprarenal inferior vena cava.Therefore, the investigation is confirmed for the filter migration.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:06/2008).
 
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 there was a cephalad migration of the filter.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced pain where the filter is placed; however, the current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Bard recovery filter was implanted below the renal veins for patient with large saddle pulmonary embolism and deep vein thrombosis.Approximately twelve years and one-month post filter deployment, computed tomography (ct) chest revealed partially visualized caval filter in the suprarenal inferior vena cava.Therefore, the investigation is confirmed for the filter migration.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 after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that there was a cephalad migration of the filter.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced pain where the filter is placed; however, the current status of the patient is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RECOVERY FILTER SYSTEM
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10004163
MDR Text Key189188257
Report Number2020394-2020-03286
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K031328
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF048F
Device Lot NumberGFPE3178
Was Device Available for Evaluation? No
Date Manufacturer Received05/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age53 YR
-
-