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

Catalog Number EC500F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Blood Loss (2597)

Event Date 05/03/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the (b)(4) materials, subassemblies, manufacturing process, and quality control testing.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 six years four months post filter deployment, computerized tomography revealed inferior vena cava filter that had fractured with 2 struts had migrated.Patient was subsequently taken to the operating room and emergently had the strut removed from the heart.A second strut was seen that had embolized into the pulmonary artery.Approximately three days later, fractured inferior vena cava filter with embolization to right ventricle and lungs resulting in pericardial effusion and retroperitoneal bleed.On the computerized tomography patient was noted to have embolized filter legs in the pericardial sac and in the rul pulmonary artery in conjunction with a juxta renal filter that appeared to be missing 2 legs.Cardiac surgery believed the filter leg penetrated the ventricular wall causing tamponade.Bent linear metallic foreign body within the ventral pericardial sac concerning for a fractured strut from the patient's inferior vena cava filter that has embolized and penetrated through the cardiac wall.Portable supine view of abdomen showed inferior vena cava filter overlies the upper lumbar spine.Approximately two days later, complex filter retrieval was scheduled.Filter tilted, but not tip embedded inferior vena cava filter with otherwise normal inferior vena cava, no clot in filter.Initial attempts at removing the filter with a snare were unsuccessful, as the filter hook could not be completely engaged by the snare.The snare was removed, and the retrieval sheath was upsized to a 16 f sheath.The filter hook was then engaged with endobronchial forceps in the jaws of life technique.It was removed successfully.Right pulmonary arteriogram demonstrated fractured inferior vena cava filter strut in an inferior right upper lobe segmental pulmonary artery branch.Therefore, the investigation is confirmed for filter tilt, filter limb detachment and retrieval difficulties.Per medical records, attempts were made to engage the filter using snare 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 documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.Expiry date: 01/2013, (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.At some time post filter deployment, it was alleged that the filter tilted, struts detached and patient reportedly diagnosed with cardiac tamponade, cardiac perforation, pericardial effusion, retroperitoneal bleeding and embolized strut retained in the pulmonary artery.The device was removed after an attempted but unsuccessful percutaneous removal procedure.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: 10539844
• MDR Text Key: 207114258
• Report Number: 2020394-2020-05679
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• 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: GFUA1253
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2013
• 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: ATENOLOL, ASPIRIN, IBUPROFEN, SILVER SULFADIAZINE; EPINEPHRINE, NOREPINEPHRINE, PHENYLETHANE; MUPIROCIN, POTASSIUM CHLORIDE, AMLODIPINE,; OXYCODONE-ACETAMINOPHEN; PENICILLIN, VANCOMYCIN, MORPHINE, HEPARIN; VASOPRESSIN, ATORVASTATIN, CALCIUM GLUCONATE
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 77