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

Model Number DL900F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976)

Patient Problem Abdominal Pain (1685)

Event Date 08/10/2017

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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately two years post filter deployment, patient presented for filter retrieval due to filter fracture and fractured strut embolized in pulmonary artery.Venogram through the sheath demonstrates the medial aspect of the ivc filter embedded within the wall of the ivc.A gooseneck snare was then advanced through the retrieval sheath and was unable to snare the hook of the filter.An 8 mm vertebral catheter was attempted to snare the hook and were unsuccessful.Forceps were also used to attempt to snare the hook and were unsuccessful.Subsequently, a sos catheter was used to direct a wire through the tines and directed cephalad.This wire was then snared and pulled out through the existing sheath.The sheath was unable to be advanced over the hook.Two of the tines became deformed and were directed cephalad.Repeat attempts were made at snaring the ivc filter and were unsuccessful including with use of a steerable 7 french sheath and a pigtail catheter.The remaining caudally directed tines of the filter and the hook could not be engaged.Approximately one month later, multiple attempts were made to remove the ivc filter without success.The filter could be grasped near the hook.The 2 legs which had been flipped superiorly were able to be looped, however, the snare could not be passed through the right groin sheath.A final attempt was made to snare the hook of the filter from the right ij access using a gooseneck snare.The course narrowed and the 16 french sheaths was advanced in order to collapsed filter, remove it from the wall and then pulled through the sheath from the neck.The migrated strut was unchanged in position within the right lower lobe pulmonary artery.The strut was able to be grasped with the gooseneck snare and pulled within the vertebral catheter which was then removed from the right groin.Therefore, the investigation is confirmed for material deformation, filter limb detachment and retrieval difficulties.However, the investigation is inconclusive for perforation of the ivc and filter tilt.Per medical records, multiple attempts were made to engage the hook of the filter using snare, sheath and forceps but were unsuccessful due to embedment.This could have contributed to the retrieval difficulties.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.(expiry date: 08/2018), (b)(4).

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 the filter tilted, strut detached and perforated into the organs.The device and detached strut were removed percutaneously after an attempted but unsuccessful percutaneous removal procedure.It was further reported that the detached strut migrated to the right lower lobe pulmonary artery was successfully retrieved during second removal procedure.The patient reportedly experienced abdominal and right-side body pain; however, 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: 9810400
• MDR Text Key: 182786054
• Report Number: 2020394-2020-01387
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• 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: GFZG3081
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 51 YR