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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM VENA CAVA FILTER Back to Search Results
Model Number DL900F
Device Problems Positioning Failure (1158); Obstruction of Flow (2423)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 09/21/2016
Event Type  Injury  
Manufacturer Narrative
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. The medical records allege bard denali filter was implanted for a patient. The filter was deployed with a little bit at an angle but there was no other complication. Approximately one year and two months later, a positron emission tomography/computed tomography skull base to midthighs was performed, showing large hypermetabolic mass in pelvis, hypermetabolic tissue filling the right iliac veins and inferior vena cava, and presence of inferior vena cava filter. The tissue was diagnosed of potential representing a combination of tumor and thrombus and bland thrombus, extending through and superior to the inferior vena cava filter with increased risk of pulmonary embolism. After nine months, a magnetic resonance imaging abdomen and pelvis was done, demonstrating presence of inferior vena cava filter and tumor thrombus obstructing the entire inferior vena cava extending into hepatic segment. Tumor was also noted obstructing the right internal iliac and common iliac veins. After one year and two months, a magnetic resonance imaging was performed on patient with continued abdominal pain, noting still massive lower extremity edema related to tumor thrombus. After two weeks, a computed tomography abdomen was done, noting markedly enlarged inferior vena cava mostly occluded and filled with tumor as well as bland thrombi extending to the right internal iliac vein. Right-sided pelvic mass was also noted. After eleven days, a computed tomography chest with contrast was done, demonstrating extensive tumor thrombus was noted in the inferior vena cava which extends into the right atrium. After one-month, inferior vena cava filter was noted embedding and irretrievable at this time. Therefore, the investigation is confirmed for the alleged positioning issue and filter occlusion. Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment. However, the relationship to the filter is unknown. Based on 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: 03/2018.
 
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 there was thrombus obstruction extending through and superior to the inferior vena cava filter. The device has not been removed and there were no reported attempts made to retrieve the filter. The current status of the patient is unknown.
 
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Brand NameDENALI FEMORAL SYSTEM
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key12390847
MDR Text Key268886097
Report Number2020394-2021-80709
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL900F
Device Catalogue NumberDL900F
Device Lot NumberGFZA0702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/31/2021 Patient Sequence Number: 1
Treatment
LETROZOLE, WARFARIN, MEGESTROL, OXYCODONE, ZOFRAN
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