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. G2 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 FILTER SYSTEM - FEMORAL; VENA CAVA FILTER Back to Search Results
Catalog Number RF310F
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Extrusion (2934)
Patient Problems No Consequences Or Impact To Patient (2199); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/18/2017
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for migration and perforation as no objective evidence has been provided to confirm any alleged deficiency with the filter.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.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported through the litigation process that sometime post vena cava filter deployment a ct scan demonstrated the ivc filter perforated, migrated, and embedded.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.
 
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 and prior to colectomy.At some time post filter deployment, a computed tomography scan demonstrated that the filter tilted, migrated to heart and struts perforated into organs.The device was removed percutaneously.The current status of the patient is unknown.
 
Manufacturer Narrative
Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately, eight years one month of post deployment, computerized tomography-abdomen without contrast was performed which showed that an inferior vena cava filter seen within the inferior vena cava.It was located near l2-l3 level.It was within the infrarenal inferior vena cava.There was evidence of inferior vena cava tilt.The position was satisfactory.The distal portion of the inferior vena cava on sagittal image demonstrated 2 mm anterior perforation.Distal portion of the inferior vena cava filter has one prong coursing medially behind the abdominal aorta with the perforation measuring approximately 10 mm away from the inferior vena cava wall.The prong extends in the retroperitoneal fat behind the aorta on axial image.A 3rd prong seen posterior to the inferior vena cava wall perforating 1 mm.After, three months and twenty-three days, angiographic findings showed that an inferior vena cava filter was placed below the level of the infrarenal inferior vena cava.As visualized, there were no areas of differential density that would suggest thrombus at the level of the inferior vena cava filter.Around, one month later, an inferior vena cava filter removal was performed via right internal jugular vein access.The vein was full and was easily accessed with a micropuncture needle.The wire tracked into the inferior vena cava without resistance.After a skin incision, the needle was exchanged for a micropuncture sheath.A j wire was advanced into the inferior vena cava near the g2 filter.The sheath was exchanged for the 12 french dilator of the gunther tulip filter retrieval set.After dilating our track and jugular access under ultrasound, the dilator was exchanged for the 11 french sheath assembly over the wire.Then removed the wire and advanced the snare system.Then snared the top of the filter successfully but was unable to collapse the filter due to tilt and small sheath size.The decided to upsize the sheath to a 16 french check flow and did so over the j wire.Then used the same snare system again in attempt to collapse the filter but was unsuccessful.They elected to use a rigid bronchoscopy forceps through the large sheath to grab the filter top.This was easily achieved.They were then able to collapse the filter by advancing the sheath over the forceps and the filter.The filter was removed from the sheath.Examination under x-ray demonstrated an intact g2 filter with all the tines.Therefore, the investigation is confirmed for the perforation of the inferior vena cava(ivc), filter tilt and retrieval difficulties.However, the investigation is inconclusive for 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.Section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
G2 FILTER SYSTEM - FEMORAL
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7659977
MDR Text Key113176286
Report Number2020394-2018-01092
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K062887
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF310F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CALCIUM-VITAMIN D, CHOLECALCIFEROL1000; CARBAMAZEPINE, B COMPLEX VITAMINS; CYMBALTA, PREDNISONE, ACETAMINOPHEN, NORCO; DIPHENOXYLATE-ATROPINE, LOSARTAN; HYDROCORTISONE, HYDROMORPHONE, REGULAR INSULIN; KETOROLAC, LORAZEPAM, METOPROLOL; LACTOBACILLUS CAP, ATORVASTATIN, CELECOXIB; LOPERAMIDE, VENLAFAXINE, ALTEPLASE; LOPRESSOR, HYDROCHLOROTHIAZIDE, ZOCOR, EFFEXOR; OXYCODONE-ACETAMINOPHEN, NYSTATIN, DULOXETINE; PARENTERAL NUTRITION, ZOLPIDEM, MULTIVITAMIN; PROCHLORPERAZINE, ONDANSETRON; SIMVASTATIN, ASPIRIN, PANTOPRAZOLE, GUAR GUM
Patient Outcome(s) Other;
Patient Age65 YR
Patient Weight87
-
-