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

Catalog Number DL900F

Device Problems Detachment of Device or Device Component (2907); Extrusion (2934); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

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 detachment and perforation 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 three years five months post vena cava filter deployment a ct scan demonstrated the filter detached and perforated beyond the ivc wall.There were no reported attempts made to retrieve the filter.The 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 after being diagnosed with deep vein thrombosis/pulmonary embolism and in conjunction with or before orthopedic procedure.Approximately three years five months post vena cava filter deployment a computed tomography scan demonstrated the filter detached and perforated beyond the inferior vena cava.At some time post filter deployment, it was alleged that the filter struts bent.The device has not been removed and there were no reported attempts made to retrieve the filter.The detached struts are located beyond the walls of the inferior vena cava posteriorly encroaching upon l3 vertebra.The patient experienced back pain; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.

Manufacturer Narrative

H10: 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.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 three years and five months later, computed tomography (ct) revealed that several filter struts located beyond the walls of the inferior vena cava.There was no involvement of adjacent organs or vessels.However, a minor bending of several of the inferior vena cava filter struts was noted.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava (ivc) and material deformation.However, the investigation is inconclusive for filter limb detachment.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: (expiry date: 03/2017).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 and in conjunction with or before orthopedic procedure.Approximately three years five months post vena cava filter deployment a computed tomography scan demonstrated the filter detached and perforated beyond the inferior vena cava.Additionally, the filter struts bent.The device has not been removed and there were no reported attempts made to retrieve the filter.The detached struts are located beyond the walls of the inferior vena cava posteriorly encroaching upon l3 vertebra.The patient experienced back pain; however, the current status of the patient is unknown.

• 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: 7580954
• MDR Text Key: 110456258
• Report Number: 2020394-2018-00824
• 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,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: GFXL1931
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 11/06/2020; 12/08/2020
• Supplement Dates FDA Received: 12/03/2020; 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 85