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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENALI JUGULAR SYSTEM; VENA CAVA FILTER
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DENALI JUGULAR SYSTEM; VENA CAVA FILTER Back to Search Results
Catalog Number DL900J
Device Problems Partial Blockage (1065); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Chest Pain (1776); Hemorrhage/Bleeding (1888); Renal Disease, End Stage (2039); Renal Failure (2041); Blood Loss (2597); Thrombosis/Thrombus (4440)
Event Date 06/09/2016
Event Type  Injury  
Manufacturer Narrative
The device history records have been reviewed with special attention to the (b)(4), 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.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive 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.(expiry date: (b)(6) 2018), (manufacturing date: 06/2015), (b)(6).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 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 patient had a partially thrombosed ivc.Furthermore, the patient allegedly experienced kidney failure, internal bleeding, and chest pain.The device was removed percutaneously.The current 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.At some time post filter deployment, it was alleged that the filter detached and perforated.The patient had a partially thrombosed ivc.Furthermore, the patient allegedly experienced kidney failure, internal bleeding, and chest pain.The device was removed percutaneously.The current status of the patient is unknown.
 
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.Medical records were not provided.Therefore, the investigation is inconclusive for the alleged perforation of the inferior vena cava and filter limb detachment 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.H10: d4 (expiry date: 06/2018),g4, h4 (manufacturing date: 06/2015), h6 (patient: 2100).H11: h6(device).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.Medical records were provided and reviewed.Approximately, seven months of post deployment, a computed tomography of abdomen was performed for abdominal pain.The study showed that an inferior vena cava filter was seen inferior to the renal vessels and no abdominal aortic aneurysm or retroperitoneal lymphadenopathy was seen.Confluence of the inferior vena cava and aortic bifurcation gives apparent density in the lower retroperitoneum anterior to the spine.On the next day, a computed tomography of abdomen was performed for a drop in hemoglobin with known bleeding.The study showed that the inferior vena cava filter remained unchanged in location and position.Around twenty-one days later, a computed tomography of abdomen was performed for budd-chiari syndrome, deep vein thrombosis and retroperitoneal hemorrhage.The study showed that there was an inferior vena cava filter present with the tip at the level of the renal veins and there was complete thrombosis of the inferior vena cava from the filter, distally into the upper lower extremities.The study concluded with an extensive occlusion of the inferior vena cava from the level of inferior vena cava filter distally to the visualized upper extremities with probable post thrombotic syndrome accounting for the collaterals and edematous change.Around, three months and twenty-five days later, through the right internal jugular vein approach, the bard denali retrievable inferior vena cava filter was removed for the patient with partially thrombosed inferior vena cava filter with distal vena cava thrombosis.The right internal jugular vein was accessed with an 18-guage needle under ultrasound guidance and was followed by a guidewire, inserted under fluoroscopy into the superior vena cava.The guidewire was then passed down into the inferior vena cava with the help of kumpe catheter.Next, the sheath and the dilator of the removal system was inserted and an inferior vena cavogram was obtained once the sheath was just above the inferior vena cava filter.The filter with the sheath was then grabbed with a snare and the filter removal sheath was pushed over it to collapse the filter.Finally, the filter was removed through the sheath.An inferior vena cavogram revealed that the thrombosis was ending directly below the takeoff of the renal veins.Based on the anatomy and concern that deploying a new filter in the partially thrombosed vena cava would potentially lead to a missed deployment and it was undesirable to deploy the filter above the takeoff of renal veins.So, it was concluded to not redeploy a new inferior vena cava filter.Therefore, the investigation is confirmed for the occlusion of the inferior vena cava (ivc).However, the investigation is inconclusive for the perforation of the inferior vena cava (ivc), and 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: 06/2018) 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.At some time post filter deployment, it was alleged that the filter detached, perforated and the patient had a partially thrombosed inferior vena cava.Furthermore, the patient allegedly experienced kidney failure, internal bleeding, and chest pain.The device was removed percutaneously.The current status of the patient is unknown.
 
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Brand Name
DENALI JUGULAR SYSTEM
Type of Device
VENA CAVA FILTER
MDR Report Key8061789
MDR Text Key126941811
Report Number2020394-2018-02006
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K130366
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 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDL900J
Device Lot NumberGFZD4319
Was Device Available for Evaluation? No
Date Manufacturer Received10/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CLONIDINE, LISINOPRIL-HYDROCHLOROTHIAZIDE; NORVASC, CARVEDILOL, PROTONIX AND OXYCODONE
Patient Outcome(s) Other;
Patient Age45 YR
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