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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 Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Extrusion (2934); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Chest Pain (1776); Great Vessel Perforation (2152); No Consequences Or Impact To Patient (2199)
Event Date 04/13/2015
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 filter detachment, perforation of the ivc, and migration 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 approximately ten years post filter deployment a ct scan demonstrated that the filter had detached, perforated, and migrated.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.
 
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 event 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 ten years post deployment, a ct demonstrated that there was a metallic strut coursing posterior to the wall of the aorta.There was also a strut coursing anterior to the aorta.Nine days later, a ct revealed that the legs of the ivc filter had penetrated the wall of the cava and lie anterior and posterior to the abdominal aorta.Approximately three weeks later, a ct showed the ivc filter with some limbs extending beyond the ivc were again noted similar in appearance to prior exam.A month later, an xr showed that the ivc filter was in place but there was an unchanged wire like foreign body projecting over the right lower chest noted.Therefore, the investigation can be confirmed for perforation of the ivc.However, the investigation is inconclusive for limb detachment as there is no evidence in the provided medical records to confirm if the unchanged wire like foreign body was from the filter.Additionally, the investigation is unconfirmed for filter migration to heart as the ivc filter was noted to be in place based on the provided medical records.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 approximately ten years post filter deployment a ct scan demonstrated that the filter had detached, perforated, and migrated.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.New information: 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.At some time post filter deployment, it was alleged that the filter perforated and migrated to the heart.Limbs detached and reportedly are posterior to the aorta wall and anterior to the aorta.The device has not been removed and there were no reported attempts made to retrieve the filter or detached limbs.The patient reportedly experiences chest paint; however, the current status of the patient is unknown.
 
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 ten years post deployment, a ct demonstrated that there was a metallic strut coursing posterior to the wall of the aorta.There was also a strut coursing anterior to the aorta.Nine days later, a ct revealed that the legs of the ivc filter had penetrated the wall of the cava and lie anterior and posterior to the abdominal aorta.Approximately three weeks later, a ct showed the ivc filter with some limbs extending beyond the ivc were again noted similar in appearance to prior exam.A month later, an xr showed that there was an unchanged wire like foreign body projecting over the right lower chest.Therefore, the investigation can be confirmed for perforation of the ivc.However, the investigation is inconclusive for filter migration.Additionally, based on the provided medical records, the investigation is inconclusive for limb detachment as there is no clear evidence that the wire like foreign body was from 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 approximately ten years post filter deployment a ct scan demonstrated that the filter had detached, perforated, and migrated.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.New information: 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.At some time post filter deployment, it was alleged that the filter perforated the ivc.Limbs detached and reportedly are posterior to the aorta wall and anterior to the aorta.The device has not been removed and there were no reported attempts made to retrieve the filter or detached limbs.The patient reportedly experienced abdominal pain; 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 Key7444074
MDR Text Key106033706
Report Number2020394-2018-00410
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 07/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF048F
Device Lot NumberGFOJ2621
Was Device Available for Evaluation? No
Date Manufacturer Received07/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COUMADIN, LORTAB, METHADONE; COUMADIN, LORTAB, METHADONE; DIVALPROEX (DEPAKOTE DR); DIVALPROEX (DEPAKOTE DR); ESCITALOPRAM OXALATE (LEXAPRO); ESCITALOPRAM OXALATE (LEXAPRO); IBUPROFEN (ADVIL, MOTRIN); IBUPROFEN (ADVIL, MOTRIN); NICOTINE (NICODERM CQ), OXYBUTYNIN (DITROPAN); NICOTINE (NICODERM CQ), OXYBUTYNIN (DITROPAN); OXYCODONE-ACETAMINOPHEN (PERCOCET), SENNA DOCUSATE; OXYCODONE-ACETAMINOPHEN (PERCOCET), SENNA DOCUSATE; TAMSULOSIN (FLOMAX); TAMSULOSIN (FLOMAX)
Patient Outcome(s) Other;
Patient Age44 YR
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