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); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problems Chest Pain (1776); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 12/11/2021

Event Type  Injury  

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with chronic pulmonary embolism.At some time, post filter deployment, it was alleged that the filter detached, filter struts perforated into adjacent tissue, tilted and the patient reportedly experienced chest pain.The device has been removed after an unsuccessful percutaneous removal procedure.The patient was diagnosed with possible hemopericardium with concern for intramural hematoma post filter implant and noted to have cardio-aortic injury; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiry date: 12/2021) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately two years and seven months post deployment, the patient experienced onset of chest pain and removal of migrated inferior vena cava filter fragment was performed in the heart.The physician assistant noted a free piece of inferior vena cava filter fragment sitting in the pericardial space abutted by the aortic arch.The filter fragment was removed.Around two months later, computed tomography arteriography/venography revealed the filter apex was tilted to the left and several of the filter legs extended outside the contours of the inferior vena cava, into adjacent tissue, but not near any critical structure.Around one month later, filter retrieval was performed.The filter was tilted to the left with most of the left-side of the filter lying along the left wall of the inferior vena cava and its apex in the central portion of the refluxed old left renal vein, lying along the superior wall of that vein.A 7 french gonadal guiding catheter along with a 5 french catheter was advanced through a twenty-three centimeter long 10 french sheath.Contrast injection showed patency of the left renal vein but moderate narrowing centrally where the apex of the filter was located.Several reverse curve catheters used with attempts made to advance a 0.018-inch guidewire through that back into the inferior vena cava, but this encountered difficulty.The wire kept coursing inferiorly overlapping the filter and then superiorly.This method of trying to capture the apical region of the filter was decided too not feasible.The guide catheter was removed along with its inner catheter.The sheath was then exchanged over an amplatz wire for a 45 centimeter long 16 french sheath.A grasping forceps was advanced through that and after several tries, the apical region of the filter was captured.The sheath was able to be advanced over the superior aspect of the filter, which time the forceps slipped off the top of the filter.Attempts to grab the hook of the filter that was now within the sheath were made with a five-millimeter gooseneck snare, but the hook was oriented along the wall of the sheath magnetic difficult.The forceps was reintroduced through the sheath and the apical region again grasped.The sheath was now advanced over the filter, freeing it completely from the wall and the filter was removed.On examination, the filter had intact six legs and five arms, compatible with no further destruction of it.The one arm that was missing was the one that had been removed at the time of the open-heart surgery.Therefore, the investigation is confirmed for perforation of inferior vena cava, filter limb detachment, filter tilt and retrieval difficulties.Per medical records, multiple attempts were made to engage the apex of the filter using snare and forceps but were unsuccessful due to filter tilt.This could have contributed to the retrieval difficulties.However, the definitive root cause is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.D4 (expiration date: 12/2021).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with chronic pulmonary embolism.Two years, six months, and twelve days post filter deployment, it was alleged that the filter struts perforated into adjacent tissue, detached and tilted.The patient reportedly experienced chest pain, was diagnosed with possible hemopericardium with concern for intramural hematoma post filter implant and noted to have cardio-aortic injury.The device has been removed after an unsuccessful percutaneous removal procedure.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 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17248229
• MDR Text Key: 318303542
• Report Number: 2020394-2023-00476
• 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: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: GFCX3103
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 09/15/2023
• 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: LEVOTHYROXINE AND ESCITALOPRAM OXALATE; LEVOTHYROXINE AND ESCITALOPRAM OXALATE
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 54 KG