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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN FILTER
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528)
Patient Problem Injury (2348)
Event Date 11/01/2006
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
 
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.The device was removed via an open chest procedure after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: 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.Medical records were provided and reviewed.Approximately one year and seven months later, a lumbar spine 2 or 3 views was performed, and it revealed an inferior vena cava filter with the superior tip at the l1-l2 disc space level.After one month later, the patient scheduled for the filter retrieval; the right internal jugular vein was accessed.The filter apex appeared to be somewhat endothelialzed and into the vessel wall.It was unable to grasp it to successfully retrieve it.After multiple attempts it was unsuccessful.Then cone retrieval apparatus was removed, and magic torque wire was placed.Despite multiple repositioning of the guidewire in reattempting to remove the filter, it was unsuccessful.The right femoral vein was accessed.The 8*4 ultra-thin udt balloon was then inflated to dilate the vena cava to peel off the apex of the filter from the vessel wall.This was done multiple times and subsequently the attempts were unsuccessful.After multiple attempts, the procedure was then aborted.Therefore, the investigation is confirmed for alleged filter migration and retrieval difficulties 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.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 after being diagnosed with deep vein thrombosis/pulmonary embolism.The device was removed via an open chest procedure after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.
 
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Brand Name
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 Key11221578
MDR Text Key228405221
Report Number2020394-2020-06552
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN FILTER
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age40 YR
Patient Weight141
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