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

Catalog Number EC500J

Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Chest Pain (1776); Thrombosis/Thrombus (4440)

Event Date 03/03/2016

Event Type  Injury  

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 four years and eleven months of post deployment, computerized tomography-abdomen/pelvis with contrast linear radiopaque density projecting over right upper lung represents a fractured tine from inferior vena cava filter.Thoracic spine x-ray showed a likely fractured piece of inferior vena cava filter in the right lung.Therefore, the investigation is confirmed for filter limb detachment.However, the investigation is inconclusive for filter migration, perforation of inferior vena cava (ivc) and thrombosis.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 11/2013).

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 migrated to cephalad, struts detached and perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The detached struts retained in right lung and the patient experienced chest pain and was diagnosed with thrombosis above the filter; however, the current status of the patient is unknown.

• Brand Name: ECLIPSE FILTER SYSTEM - JUGULAR
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12119640
• MDR Text Key: 260018965
• Report Number: 2020394-2021-01285
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500J
• Device Lot Number: GFUJ2242
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• 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: ARIXTRA, IMODIUM, CEFEPIME; BROMFENAC, DICLOFENAC SODIUM, FLUTICASONE; CLINDAMYCIN, ZOSYN, DIFLUCAN; DIPHENHYDRAMINE, NITROGLYCERIN, PANTOPRAZOLE; FUROSEMIDE, LORAZEPAM, MOXIFLOXACIN; PIPERACILLIN-TAZOBACTAM AND CISPLATIN; PROCHLORPERAZINE, PROZAC, CLONAZEPAM; SIMVASTATIN, NEXIUM, DEXAMETHASONE; TRIAMCINOLONE, TOPOTECAN, TAXOL; VANCOMYCIN, ACETAMINOPHEN, ZOFRAN; ZOLPIDEM ONDANSETRON, TRAMADOL,
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 82