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

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.

• 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
• 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 Key: 12390847
• MDR Text Key: 268886097
• Report Number: 2020394-2021-80709
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFZA0702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• 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 Sequence Number: 1
• Treatment: LETROZOLE, WARFARIN, MEGESTROL, OXYCODONE, ZOFRAN
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 66 YR
• Patient Weight: 98