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

Model Number DL900F

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 11/09/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and 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.Bard denali filter was implanted just below the renal vein.On the next day, a portable chest x-ray revealed the inferior vena cava filter was noted in the right atrium previously pointed cranially and to the right was rotated clockwise approximately 100-degrees.The apex of the inferior vena cava filter protruded into the tricuspid valve region with the legs projected within the right atrium and attempt was made to dislodged inferior vena cava filter from the right atrium and tricuspid valve.Using the seldinger technique left subclavian trauma line was placed and the right subclavian indwelling central line was removed as it freely migrated in and out of the tissues.A standard median sternotomy was performed.The inspection of the heart revealed that the filter was easily palpable within the right atrium.In addition, at the inferior vena cava region, there appeared to be a near perforation of the cava at that level.Cardiopulmonary bypass was then instituted after heparinization was adequate and the aorta was cross clamped.A right atriotomy was performed and the filter was easily visualized, grasped with forceps, dislodged from its hooks, and dislodged from the surrounding tissues.The retrieval hook had been entangled in the tricuspid valve and this was gently removed, preserved the valve, which was competent after removal of the filter.The right atriotomy was then closed in a 2-layer fashion.Approximately one week five days later, an angel catheter inferior cava filter was placed at l1-l2 disc interspace.Subsequently, twelve days later, angel catheter inferior vena cava filter and right femoral central venous catheter were removed as a unit.Therefore, the investigation is confirmed for filter tilt, filter migration, and perforation of the inferior vena cava (ivc).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: 09/2018).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter migrated to the heart and struts perforated to the organs.The device was removed via an open chest procedure.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: 10177578
• MDR Text Key: 195901421
• Report Number: 2020394-2020-03999
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFZG3138
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2015
• 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; Required Intervention
• Patient Age: 27 YR