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

Catalog Number EC500F

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)

Patient Problem Injury (2348)

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 review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, eight years of post-deployment, the patient scheduled for the filter retrieval.In the patient history notes, it was stated an attempt was made to remove the filter, however, the filter was noted to be tilted with at least two of the struts extravascular.Attempts to remove the filter at that time were unsuccessful.A follow up computed tomography (ct) abdomen and pelvis with contrast was revealed extravascular placement of at least three of the filter legs contacting the lateral wall of the aorta and the fourth filter leg contacting the vertebral body with associated sclerotic osseous reaction.An inferior vena cava filter with extravascular filter leg migration.The filter was removed successfully.Therefore, the investigation confirmed for the perforation of the inferior vena cava(ivc), filter tilt and retrieval difficulties.However, the investigation is inconclusive for filter migration and filter limb detachment.Based upon 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: 04/2013), (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 filter migrated to heart, tilted, struts detached and perforated.The device has been removed percutaneously after an attempted but unsuccessful percutaneous removal procedure.There are three filter struts located in aortic wall, fourth strut contacting vertebral body with associated sclerotic osseous reaction.The current status of the patient is unknown.

• Brand Name: ECLIPSE FILTER SYSTEM - FEMORAL
• 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: 11035199
• MDR Text Key: 222283057
• Report Number: 2020394-2020-06499
• 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: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• 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: GFUC2267
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• 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
• Treatment: ALBUTEROL, CETIRIZINE, DICLOFENAC, FLUTICASONE; NASAL SPRAY AND MELOXICAM
• Patient Outcome(s): Other