• 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. G2 X 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. G2 X FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF400F
Device Problem Obstruction of Flow (2423)
Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)
Event Date 05/15/2017
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. After two days later, an ultrasound extremity venous upper bilateral showed no evidence of deep venous thrombosis in the internal jugular veins, subclavian veins, axillary veins, brachial veins, basilic veins or cephalic veins on either side. After eight years and one month later, an ultrasound bilateral lower extremities showed an inferior vena cava filter and possibility of inferior vena cava filter occlusion. On the next day, the patient presented with worsening abdominal pain and diagnosed with an occluded inferior vena cava filter. On the same day, a bilateral lower extremity venogram showed clot in left leg, that extended from popliteal vein all the way to 3 cm above the filter. The clot in the right leg started in superficial femoral vein to the inferior vena cava filter and low placement of the inferior vena cava filter. Also, a computed tomography (ct) abdomen, pelvis and bilateral lower extremities with intravenous contrast showed extensive pulmonary artery emboli on the right. An infra renal inferior vena cava filter was in place. There was a massive acute left retroperitoneal hematoma. After two days, an x-ray abdomen 1 view portable showed that an inferior vena cava filter overlay the l4 vertebral body. After four days, a computed tomography (ct) chest and abdomen without intravenous contrast showed that an inferior vena cava filter tip was caudal to the renal vein confluence. After one year and three weeks, the patient presented with occluded left iliac vein stent. On the same day, a venogram demonstrated that the inferior vena cava filter was patent. Also, a computed tomography (ct) abdomen and pelvis without intravenous contrast showed the presence of an infra renal inferior vena cava filter. Therefore, the investigation is confirmed for the alleged filter occlusion. Additionally, it can be confirmed that the patient experienced thrombus above the filter and pulmonary embolism post deployment. However, the relationship to the filter is unknown. 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: 02/2012).
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary embolism. Approximately eight years and one month post filter deployment, it was alleged that the filter was occluded. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient was diagnosed with thrombus above the filter and right extensive pulmonary artery emboli post filter implant; however, the current status of the patient is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameG2 X 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 Key12126913
MDR Text Key260216032
Report Number2020394-2021-80541
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082305
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 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF400F
Device Lot NumberGFTA2089
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
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: 07/07/2021 Patient Sequence Number: 1
Treatment
CARVEDILOL, DEXAMETHASONE, LASIX AND NEURONTIN; COZAAR, NIMBEX, LIPITOR, COREG AND MYLICON; OXYCONTIN, LYRICA, NORCO, ECOTRIN AND ATORVASTATIN; ULTRAM, COUMADIN, LOVENOX AND FERROCITE
-
-