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

Model Number DL900F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)

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.Approximately one month of post deployment, the patient admitted to the hospital with lower extremity pain and swelling, in the patient consultation notes it was reported about 2 weeks ago, the patient was diagnosed with pulmonary embolism and extensive bilateral deep vein thrombosis.An ultrasound lower extremity was performed, and it revealed there was likely thrombosis from the inferior vena cava at the level of the filter down into the iliac veins and bilaterally into the lower extremities.The next day, a venogram was performed and it revealed thrombus was identified above and below the filter.Subsequently an angiojet was used to remove thrombus from the external iliac and common iliac veins bilaterally.Finally, additional tpa infusion therapy was initiated at 1mg per hour through each infusion catheter.The next day, a venogram was performed and it revealed the thrombus within the inferior vena cava including within the filter and superior to the filter has resolved.10cm long infusion catheters were placed in bilateral common femoral and external iliac veins for targeted tpn fusion.Continued infusion at the same rate was planned for overnight and a follow up venogram was planned.The next day, infrarenal inferior vena cava was now clear and filter shows no evidence of adjacent clot.Tpa infusion was stopped at this time.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Additionally, it can be confirmed that the patient experienced pulmonary embolism and 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: 03/2020).

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.At some time post filter deployment, it was alleged that the patient was diagnosed with pulmonary embolism and thrombus above the 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: 11973215
• MDR Text Key: 255347680
• Report Number: 2020394-2021-80495
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• 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: GFBP3336
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• 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: LAMOTRIGINE AND OXYCODONE
• Patient Outcome(s): Life Threatening; Other