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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM; VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Malposition of Device (2616); Extrusion (2934); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); No Consequences Or Impact To Patient (2199)
Event Date 12/03/2017
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 tilt and perforation of the ivc 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 the filter tilted and multiple limbs perforated the vena cava with some limbs contacting the duodenum and extending into the anterior aspect of the vertebral space.There were no reported attempts to retrieve the filter.The status of the patient is unknown.
 
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 tilt and perforation of the ivc 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.
 
Event Description
It was reported through the litigation process that sometime post vena cava filter deployment the filter tilted and multiple limbs perforated the vena cava with some limbs contacting the duodenum and extending into the anterior aspect of the vertebral space.There were no reported attempts to retrieve the filter.The status of the patient is unknown.
 
Manufacturer Narrative
H10: 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.Approximately ten months later, the patient presented with abdominal pain.After eleven years and seven months, a computed tomography abdomen without contrast was performed which showed an infrarenal inferior vena cava filter was in place.The filter was tilted medially.The angle of tilt was approximately 7 degrees medially when compared with the plain of the long axis of the inferior vena cava.There was no contact between the tip of the filter and walls of the inferior vena cava.A posterior strut of the filter extended into the anterior aspect of the l3-l4 intervertebral disc space.There was 5mm distance between the posterior wall of the inferior vena cava and the tip of this posterior strut.There were additional posterior struts also which extended beyond the posterior margin of the inferior vena cava.These might be in the lumbar collateral veins.One of the medial struts extended medially and slightly anteriorly beyond the margins of the inferior vena cava.The tip of this strut appeared to be contacting the right lateral wall of the aorta.There appeared to be extension of the tip of the strut into the wall of the aorta on coronal reconstructions.However, this could not be confirmed on axial plane.The structure likely terminated at the level of the wall of the aorta.One of the posterior lateral struts of the filter extended beyond the margin of the inferior vena cava.One of the anterior struts contacted the posterior wall of the duodenum.There was however, no evidence of perforation of the duodenum.There were several other structures that appeared to extend beyond the margin of the inferior vena cava.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava.However, the investigation is unconfirmed for alleged filter tilt.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 tilted and struts perforated the vena cava with some limbs contacting the duodenum and extending into the anterior aspect of the vertebral space.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient experienced pain in abdomen on the right side; however, the current status of the patient is unknown.
 
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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 Key7665013
MDR Text Key113288351
Report Number2020394-2018-01111
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 01/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF048F
Device Lot NumberGFOJ0830
Was Device Available for Evaluation? No
Date Manufacturer Received12/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
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