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

Model Number DL900J

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Cardiac Arrest (1762); Blood Loss (2597)

Event Date 12/16/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Medical record review: an inferior vena cava filter was deployed via the right internal jugular vein for a preoperative diagnosis of deep vein thrombosis and contraindication to anticoagulation due to history of gastrointestinal bleed.Inferior venacavogram demonstrated no evidence of thrombus or anomaly.The filter was deployed in the inferior vena cava below the renal veins.Post venacavogram demonstrated the successful placement of the filter.Approximately six months post filter deployment, a difficult ivc filter retrieval was successfully performed using a loop snare, 8 french catheter, 5 french catheter, 14 french sheath and endobronchial forceps.Post filter removal images demonstrated a fractured inferior vena cava filter leg positioned within the inferior vena cava.A loop snare was then advanced and the fractured filter leg was successfully removed.Inferior venacavogram performed through the sheath demonstrated satisfactory appearance of the inferior vena cava without evidence of significant bleeding or extravasation.The inferior vena cava remained patent.At the end of the procedure, the patient became acutely unresponsive to verbal and painful stimuli.Code blue was called for additional medical support (details not provided).A ct of chest abdomen & pelvis performed for inferior vena caval filter removal and cardiac arrest in interventional radiology revealed the inferior vena cava with a small amount of retroperitoneal hemorrhage present posterior to the right of the inferior vena cava, and centered at the level of the kidney.Ultrasound of the peripheral vascular system performed revealed development of nonocclusive deep vein thrombosis within the right popliteal vein measuring 4.3 cm.No evidence of deep vein thrombosis within the left leg was noted.Hemoglobin was noted to be 9.5.Hemoglobin was 9.2 in the morning and 8.9 in the afternoon.Patient was noted to be on xarelto on admission and discharge.The current condition of the patient is unknown.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Therefore, the investigation can be confirmed for limb detachment and retrieval difficulties.Per the provided medical records, the detached limb was discovered following a difficult retrieval procedure using a loop snare, 8 french catheter, 5 french catheter, 14 french sheath and endobronchial forceps.The difficult retrieval procedure could have resulted in the detached filter limb.However, 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.

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 a filter limb detached resulting in tear causing retroperitoneal bleeding.The patient became hypotensive and a code blue was called. the device and the detached filter limb were removed percutaneously. the current status of the patient is unknown.

• Brand Name: DENALI JUGULAR 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8152886
• MDR Text Key: 130072683
• Report Number: 2020394-2018-02188
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR