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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. RECOVERY VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problems Cardiac Arrest (1762); Thrombus (2101); Cardiac Perforation (2513)
Event Date 05/23/2011
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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Approximately, six years and eight months post deployment, the patient underwent cardiac catheterization.An incidental finding was a fractured strut from an ivc filter identified to be lodged in the pulmonary artery.Also identified was another strut which was broken and appeared to be in the ivc.Approximately, ten years and five months post deployment, patient underwent coronary angiogram and it was noted that a foreign body within the pulmonary artery, presumably a strut had migrated.Two weeks later, x-ray showed only four external struts.A ct scan showed streak artifact from a small metallic foreign body within the right atrium.This may represent known embolized ivc filter strut.Ivc filter with a few missing struts related to known fracture.The struts extend through the wall of the ivc into the adjacent soft tissues.Therefore, the investigation can be confirmed for perforation of the ivc and limb detachment.However, the investigation is inconclusive for retrieval difficulties.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 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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter perforated the ivc.Detached limbs reportedly remain in the right atrium and ivc.The device has not been removed and there were no reported attempts made to retrieve the filter or detached limbs.The patient reportedly experienced cardiac arrest; however, the current status of the patient is unknown.
 
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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, six years and eight months post deployment, the patient underwent cardiac catheterization.An incidental finding was a fractured strut from an ivc filter identified to be lodged in the pulmonary artery.Also identified was another strut which was broken and appeared to be in the ivc.Approximately, ten years and five months post deployment, patient underwent coronary angiogram and it was noted that a foreign body within the pulmonary artery, presumably a strut had migrated.The ecg showed a small apical thrombus, noted in the left ventricle and left upper extremity dvt was found on venous duplex on same day.Few days later, x-ray showed only four external struts.A ct scan showed streak artifact from a small metallic foreign body within the right atrium.This may represent known embolized ivc filter strut.Ivc filter with a few missing struts related to known fracture.The struts extend through the wall of the ivc into the adjacent soft tissues.Therefore, the investigation can be confirmed for perforation of the ivc and limb detachment.However, the investigation is inconclusive for retrieval difficulties.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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.H11: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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter perforated the ivc.Detached limbs reportedly remain in the right atrium and ivc.The device has not been removed and there were no reported attempts made to retrieve the filter or detached limbs.The patient reportedly experienced cardiac arrest; however, the current 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 in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter perforated the ivc.Detached limbs reportedly remain in the right atrium and ivc.The device has not been removed and there were no reported attempts made to retrieve the filter or detached limbs.The patient reportedly experienced cardiac arrest; however, the current status of the patient is unknown.
 
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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, six years and eight months post deployment, the patient underwent cardiac catheterization.An incidental finding was a fractured strut from an ivc filter identified to be lodged in the pulmonary artery.Also identified was another strut which was broken and appeared to be in the ivc.Approximately, ten years and five months post deployment, patient underwent coronary angiogram and it was noted that a foreign body within the pulmonary artery, presumably a strut had migrated.The ecg showed a small apical thrombus, noted in the left ventricle and left upper extremity dvt was found on venous duplex on same day.Few days later, x-ray showed only four external struts.A ct scan showed streak artifact from a small metallic foreign body within the right atrium.This may represent known embolized ivc filter strut.Ivc filter with a few missing struts related to known fracture.The struts extend through the wall of the ivc into the adjacent soft tissues.Therefore, the investigation can be confirmed for perforation of the ivc and limb detachment.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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.
 
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Brand Name
RECOVERY VENA CAVA FILTER
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key8588609
MDR Text Key144405869
Report Number2020394-2019-00552
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,Followup
Report Date 01/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF048F
Device Lot NumberGFOG0042
Was Device Available for Evaluation? No
Date Manufacturer Received01/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COUMADIN; COUMADIN; COUMADIN
Patient Outcome(s) Life Threatening; Other;
Patient Age26 YR
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