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

Catalog Number EC500F

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem Embolism/Embolus (4438)

Event Date 11/30/2019

Event Type  Injury  

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient with deep vein thrombosis.Approximately seven years one month and thirteen days later post filter deployment, it was alleged that the filter tilted, strut detached and migrated into the right ventricle.It was further reported that patient was diagnosed with pulmonary embolism.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient was unknown.

Manufacturer Narrative

H10: 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.Approximately seven years and one month post filter deployment, a computed tomography angiogram of chest was performed for chest pain showed that fairly extensive bilateral pulmonary emboli noted.The study concluded that evidence of fairly extensive bilateral acute pulmonary emboli.Around two days later, a bilateral lower extremity venous ultrasound showed bilateral above knee-deep vein thrombosis.Around six days later, an x-ray abdomen was performed for nasogastric tube placement showed that filter was noted over the spine.Around three months and twenty-six days later, a computed tomography of thorax, abdomen and pelvis without contrast study was performed for filter migration showed that suspected metallic linear structure seen in the right ventricle, measuring approximately 2.8 cm in length, with a single angulation, and concerning for a possible embolized fractured inferior vena cava leg.The filter seen which was tilted.It was difficult to access all the legs strut on this scan without correlating a film study.The leg at the 3 o¿clock position appears quite short, concerning for fracture.Around three days later, a transesophageal echocardiogram was performed which showed linear echo density in the right ventricle, extending from right ventricle apex to the mid right ventricle cavity, measuring approximately 4.0 cm in length.This could represent a broken/dislodged piece of a catheter/wire.Therefore, the investigation is confirmed for the filter tilt, filter migration and filter strut detachment.Additionally, it can be confirmed that the patient experienced pe post deployment.However, the relationship to the filter is unknown.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 07/2015).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.

• Brand Name: ECLIPSE FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 18450127
• MDR Text Key: 332170267
• Report Number: 2020394-2023-01356
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093659
• 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
• Report Date: 12/13/2023

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 Catalogue Number: EC500F
• Device Lot Number: GFWF3269
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2012
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male