MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM; VENA CAVA FILTER

Catalog Number DL900F

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Extrusion (2934); Patient Device Interaction Problem (4001)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 06/19/2017

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 review: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for tilt, migration, 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 perforated, migrated and tilted.There were no reported attempts to retrieve the filter.Reportedly, the patient developed deep vein thrombosis; however, the status of the patient is unknown.

Event Description

It was reported through the litigation process that sometime post vena cava filter deployment the filter perforated, migrated and tilted.The filter allegedly caused the patient to develop deep vein thrombosis within the filter itself.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 and in conjunction with or before orthopedic procedure.At some time post filter deployment, it was alleged that the entire filter migrated to heart, tilted and embedded in wall of the ivc, struts perforated into the organs.The device was removed percutaneously.The current 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 (dhr) review is not required.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 two years post filter deployment, ct revealed an ivc filter was present in the infra renal ivc and the superior tip of the filter was angled slightly rightward, abutting the right inferior vena caval wall.The tines have the appearance of extending slightly beyond the margin of the caval wall, although this may relate to stretching of the ivc rather than short distance perforation.Approximately three months later, patient presented for filter removal.Subsequent, cat scan revealed ivc filter without significant access tilt and no significant clot burden.The filter was then pulled into the 9-french sheath which was then removed.The filter was then inspected and there was a small amount of clot adherent to the limbs of the filter.Therefore, the investigation is inconclusive for filter tilt and perforation of the ivc.However, the investigation is unconfirmed for filter migration to heart as the ivc filter was retrieved from ¿infra renal ivc¿.Based on the provided medical records, there is no clear evidence to confirm for perforation of the ivc and filter tilt as it reported that the tines have the appearance of extending slightly beyond the margin of the caval wall, although this ¿may relate to stretching of the ivc rather¿ than short distance perforation and an ivc filter ¿without significant access 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.H10: b5,b7,d4(expiry date: 01/2018),g3,g4.H11: b1,d1,d4,h1,h6(patient),h6(device),h6(method),h6(result).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.

• Brand Name: DENALI FEMORAL SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7659510
• MDR Text Key: 113074723
• Report Number: 2020394-2018-01080
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DL900F
• Device Lot Number: GFYL3374
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HYDROCHLOROTHIAZIDE, CLONAZEPAM, FLONASE; PRAVASTATIN, ZETIA, METOPROLOL
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 89